38 results on '"Ruiz, Fabrice"'
Search Results
2. Association between culture and the preference for, and perceptions of, 11 routes of medicine administration: A survey in 21 countries and regions
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Murdan, Sudaxshina, Wei, Li, van Riet-Nales, Diana A., Gurmu, Abyot Endale, Usifoh, Stella Folajole, Tăerel, Adriana-Elena, Yıldız-Peköz, Ayca, Krajnović, Dušanka, Azzopardi, Lilian M., Brock, Tina, Fernandes, Ana I., dos Santos, André Luis Souza, Anto, Berko Panyin, Vallet, Thibault, Lee, Eunkyung Euni, Jeong, Kyeong Hye, Akel, Marwan, Tam, Eliza, Volmer, Daisy, Douss, Tawfik, Shukla, Sharvari, Yamamura, Shigeo, Lou, Xiaoe, van Riet, Bauke H.G., Usifoh, Cyril O., Duwiejua, Mahama, Ruiz, Fabrice, and Furnham, Adrian
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- 2023
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3. A review of paediatric injectable drug delivery to inform the study of product acceptability – An introduction
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Ruiz, Fabrice, Nunn, Anthony, Gill, Andrea, Clapham, David, Fotaki, Nikoletta, Salunke, Smita, Cram, Anne, and O'Brien, Fiona
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- 2023
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4. Real-world evaluation of ceftolozane/tazobactam therapy and clinical outcomes in France
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Castan, Bernard, Akrich, Brune, Levy-Bachelot, Laurie, Amode, Anna, Berthelot, Anne, Mackosso, Carole, Mathis, Lucie, Mootien, Joy, Ruimy, Raymond, Ruiz, Fabrice, Timsit, Jean-François, and Boutoille, D.
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- 2021
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5. Acceptability of generic versus innovator oral medicines: not only a matter of taste
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Tuleu, Catherine, Hughes, Dyfrig A., Clapham, David, Vallet, Thibault, and Ruiz, Fabrice
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- 2021
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6. Anticholinergic Activity of Psychotropic Drugs and Cognitive Impairment Among Participants Aged 45 and Over: The CONSTANCES Study
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Ziad, Abdelkrim, Berr, Claudine, Ruiz, Fabrice, Bégaud, Bernard, Lemogne, Cédric, Goldberg, Marcel, Zins, Marie, and Mura, Thibault
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- 2021
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7. How the new European data protection regulation affects clinical research and recommendations?
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Bertoye, Pierre-Henri, Boidin, Romain, Bureau, Serge, Chrétien, Jean-Marie, Delval, Cécile, Deplanque, Dominique, Dubray, Claude, Duchossoy, Luc, Edel, Valérie, Fouret, Cécile, Galaup, Ariane, Lesaulnier, Frédérique, Matei, Mihaela, Naudet, Florian, Plattner, Valérie, Rubio, Michel, Ruiz, Fabrice, Sénéchal-Cohen, Sophie, Simon, Tabassome, Vidal, Anne, Viola, Anne, Violleau, Mireille, Demotes-Mainard, Jacques, Cornu, Catherine, and Guérin, Aurélie
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- 2019
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8. Methodologies for assessing the acceptability of oral formulations among children and older adults: a systematic review
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Ranmal, Sejal R., O’Brien, Fiona, Lopez, Felipe, Ruiz, Fabrice, Orlu, Mine, Tuleu, Catherine, Walsh, Jennifer, and Liu, Fang
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- 2018
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9. Ceftolozane/Tazobactam for the Treatment of Complicated Infections in Hospital Settings—A French Real-world Study.
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Timsit, Jean-François, Mootien, Joy, Akrich, Brune, Bourge, Xavier, Brassac, Isabelle, Castan, Bernard, Mackosso, Carole, Tavares, Linsay Monteiro, Ruiz, Fabrice, Boutoille, David, and Ruimy, Raymond
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URINARY tract infections ,KLEBSIELLA pneumoniae ,INTRA-abdominal infections ,TAZOBACTAM ,PSEUDOMONADACEAE ,PSEUDOMONAS aeruginosa ,TREATMENT failure - Abstract
Background This study describes the conditions of use of ceftolozane/tazobactam (C/T) and associated outcomes in French hospital settings. Methods This was a prospective, multicenter, French observational study. Patients who received at least 1 dose of C/T were included and followed up as per routine clinical practice, until stop of C/T. Results A total of 260 patients were enrolled between October 2018 and December 2019 in 30 centers across France. Of these, 177 (68.0%) received C/T as per indication of usage following the results of the antibiogram (documented cases). Among documented patients, the mean age was 61.8 years, 73.4% were males, and 93.8% presented with multidrug-resistant (MDR) bacteria at inclusion. C/T was most frequently prescribed for pneumonia (48.6%), bacteremia (14.7%), complicated intra-abdominal infections (13.0%), or complicated urinary tract infections (9.6%). Pseudomonas aeruginosa was the species most frequently isolated with 212 strains from 155 patients, and 96.2% of these strains were susceptible to C/T. The median duration of C/T treatment was 16.1 days (1–115, n = 176). Complete or partial cure was achieved in 71.7% of patients, C/T was discontinued upon adaptation to microbiology results in 11.3% of patients for the following reasons: treatment failure in 2.8%, death in 4.0%, adverse events in 1.7%, and other in 8.5%. Conclusions This is the first prospective observational study of C/T utilization in a health care setting enrolling many patients in France. C/T demonstrated a high rate of clinical effectiveness in MDR infections, confirming it as an effective treatment option for complicated infections in a high-risk population. [ABSTRACT FROM AUTHOR]
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- 2024
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10. Dosage Forms Suitability in Pediatrics: Acceptability of Antibiotics in a German Hospital.
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Klingmann, Viviane, Vallet, Thibault, Münch, Juliane, Wolters, Lena, Stegemann, Robin, Bosse, Hans Martin, and Ruiz, Fabrice
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MEDICAL personnel ,RESTRAINT of patients ,CHILDREN'S hospitals ,ANTIBIOTICS ,PEDIATRIC therapy ,PATIENT compliance ,SECLUSION of psychiatric hospital patients - Abstract
Although drug acceptability can have a significant impact on patient adherence in pediatric therapy, data are limited, even for common therapeutic areas. We present the second part of an acceptability study conducted at the University Children's Hospital Düsseldorf, Germany. The study investigated the acceptability of most commonly used antibiotics in a pediatric hospital setting. The researchers used the acceptability reference framework to score the acceptability of five antibiotics based on 150 real-life observer reports of medicine intake. Four antibiotics assessed in this study were formulated as preparations for injection (ampicillin, ampicillin/sulbactam, ceftriaxone, and gentamicin) and one as a powder for oral liquid suspension (co-amoxiclav). All the antibiotics formulated as preparations for injection were rated negatively due to high rates of negative reactions (80%), the use of restraint (51%), the use of extra devices (99%), and long preparation and administration times (100%). The antibiotic formulated as a powder was significantly more well accepted. The study concluded that there is a lack of appropriate formulations for antibiotics for use in children. These findings are important in improving knowledge on acceptability drivers and might help in formulating and prescribing better medicines for children. The study highlights the need for healthcare professionals to have knowledge about the acceptability of different products to select the best-adapted product for each patient. [ABSTRACT FROM AUTHOR]
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- 2023
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11. A Guide to Best Practice in Sensory Analysis of Pharmaceutical Formulations †.
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Clapham, David, Belissa, Emilie, Inghelbrecht, Sabine, Pensé-Lhéritier, Anne-Marie, Ruiz, Fabrice, Sheehan, Liz, Shine, Margaret, Vallet, Thibault, Walsh, Jennifer, and Tuleu, Catherine
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CHILD patients ,PATIENT compliance ,BEST practices ,SENSORY evaluation ,NEW product development - Abstract
It is well established that treatment regime compliance is linked to the acceptability of a pharmaceutical formulation, and hence also to therapeutic outcomes. To that end, acceptability must be assessed during the development of all pharmaceutical products and especially for those intended for paediatric patients. Although acceptability is a multifaceted concept, poor sensory characteristics often contribute to poor patient acceptability. In particular, poor taste is often cited as a major reason for many patients, especially children, to refuse to take their medicine. It is thus important to understand and, as far as possible, optimise the sensory characteristics and, in particular, the taste/flavour/mouthfeel of the formulation throughout the development of the product. Sensory analysis has been widely practiced, providing objective data concerning the sensory aspects of food and cosmetic products. In this paper, we present proposals concerning how the well-established principles of sensory analysis can best be applied to pharmaceutical product development, allowing objective, scientifically valid, sensory data to be obtained safely. We briefly discuss methodologies that may be helpful in reducing the number of samples that may need to be assessed by human volunteers. However, it is only possible to be sure whether or not the sensory characteristics of a pharmaceutical product are non-aversive to potential users by undertaking sensory assessments in human volunteers. Testing is also required during formulation assessment and to ensure that the sensory characteristics remain acceptable throughout the product shelf life. We provide a risk assessment procedure to aid developers to define where studies are low risk, the results of a survey of European regulators on their views concerning such studies, and detailed guidance concerning the types of sensory studies that can be undertaken at each phase of product development, along with guidance about the practicalities of performing such sensory studies. We hope that this guidance will also lead to the development of internationally agreed standards between industry and regulators concerning how these aspects should be measured and assessed throughout the development process and when writing and evaluating regulatory submissions. Finally, we hope that the guidance herein will help formulators as they seek to develop better medicines for all patients and, in particular, paediatric patients. [ABSTRACT FROM AUTHOR]
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- 2023
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12. Standardised evaluation of medicine acceptability in paediatric population: reliability of a model
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Vallet, Thibault, Ruiz, Fabrice, Lavarde, Marc, Pensé‐Lhéritier, Anne‐Marie, and Aoussat, Ameziane
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- 2018
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13. A Decision Support Tool Facilitating Medicine Design for Optimal Acceptability in The Older Population
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Vallet, Thibault, Belissa, Emilie, Laribe-Caget, Sandra, Chevallier, Alain, Chedhomme, François-Xavier, Leglise, Patrick, Piccoli, Matthieu, Michelon, Hugues, Bloch, Vanessa, Meaume, Sylvie, Grancher, Anne-Sophie, Bachalat, Nathalie, Boulaich, Imad, Abdallah, Fattima, Rabus, Maite, Rwabihama, Jean-Paul, Ribemont, Annie-Claude, Lachuer, Celia, Perquy, Ines, Lechowski, Laurent, Delahaye, Anne, Depoisson, Mathieu, Orven, Yann, Guinot, Caroline, Gibaud, Stephane, Michel, Corinne, Mahiou, Abdel, Belbachir, Sid-Ahmed, Trouvin, Jean-Hugues, Dufaÿ-Wojcicki, Amelie, Boudy, Vincent, and Ruiz, Fabrice
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- 2018
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14. Proposed Tool to Compare and Assess the Applicability of Taste Assessment Techniques for Pharmaceuticals
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Clapham, David, Bennett, Joanne, Cram, Anne, Discihnger, Angela, Inghelbrecht, Sabine, Pensé-Lhéritier, Anne-Marie, Ruiz, Fabrice, Salunke, Smita, Schiele, Julia, Soto, Jessica, Walsh, Jennifer, and Tuleu, Catherine
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- 2022
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15. Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project.
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Moretti, Francesco, Ruiz, Fabrice, Bonifazi, Fedele, Pizzo, Elena, and Kindblom, Jenny M.
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TECHNOLOGY assessment , *MEDICAL technology , *TECHNOLOGICAL innovations , *CHILD patients , *PEDIATRICS , *HEALTH services accessibility - Abstract
The medicine development process is complex and requires time and effort to ensure safety, efficacy and quality. In paediatrics, this process is even more challenging, as it involves a subgroup of the population that already faces a considerable gap in the clinical evaluation of medicines and devices compared to the adult population. Moreover, access to therapies is heavily influenced by national health technology assessment (HTA) recommendations, which often form the basis for pricing and reimbursement decisions that affect the availability of effective treatments within the national health systems. Yet performing an HTA to assess the relative effectiveness and cost‐effectiveness of a new children's treatment has several non‐trivial implications, creating a critical issue for the paediatric population. In addition, the advent of innovative health technologies for children emphasises the need to empower the role of HTAs in paediatrics. This article aims at describing the most relevant elements of the drug development process in the paediatric field by focusing on the HTA. Particular attention will be paid to the factors that influence market access for new paediatric medicines and patients' access to treatment. The article will also highlight some central methodological challenges in conducting HTA in the paediatric field. Finally, the article will provide insight into how initiatives, such as conect4children, may subsequently reinforce HTA awareness in the paediatric community and strengthen collaborations through network mechanisms. [ABSTRACT FROM AUTHOR]
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- 2022
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16. Acceptability of different oral dosage forms in paediatric patients in hospital setting.
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Pokharkar, Varsha, Sajith, Manjusha, Vallet, Thibault, Akshantal, Shruti, Shah, Rathin, Ruiz, Fabrice, and Salunke, Smita
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HOSPITALS ,DRUG tablets ,ORAL drug administration ,CROSS-sectional method ,DRUGS ,GENETIC techniques ,DOSAGE forms of drugs - Abstract
Objective: The understanding of acceptability of existing dosage forms is limited in most of the world and hinders the development of acceptable, age-appropriate medicines. The attributes of paediatric medicine acceptability may differ from country to country based on culture, healthcare infrastructure and health policies. This study was designed to map the acceptability of oral medicines in paediatric patients treated in hospital in India.Methods: An observational, cross-sectional study was conducted in patients aged below 18 years and taking any form of oral medication. Acceptability scores were obtained using CAST-ClinSearch Acceptability Score Test tool.Findings: 490 patients were recruited and 193 evaluations of different pharmaceutical products available in 20 dosage forms and 7 routes of administration were studied. Oral liquids (50%) and tablets (35%) were the most commonly prescribed and administered forms. Regardless of the therapeutic class and age, the oral liquids were 'positively accepted' in infants and toddlers. Acceptability of tablets improved with age and appeared to be generally good from the age of 6.Conclusion: This study indicates the limited progress towards adoption of age-appropriate dosage forms in India and thus impact on the acceptability of existing oral dosage forms. The key challenges posed by the adoption of age-appropriate formulations in India are (1) awareness of importance of appropriate administration and acceptability of medicines to children in India, (2) availability of age-appropriate dosage forms and (3) lack of child-appropriate medicine policies. [ABSTRACT FROM AUTHOR]- Published
- 2022
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17. The CONSTANCES Cohort Biobank: An Open Tool for Research in Epidemiology and Prevention of Diseases
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Henny, Joseph, Nadif, Rachel, Le Got, Stéphane, Lemonnier, Sylvie, Ozguler, Anna, Ruiz, Fabrice, Beaumont, Katy, Brault, Dominique, Sandt, Estelle, Goldberg, Marcel, Zins, Marie, Cohortes épidémiologiques en population (CONSTANCES), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université de Paris (UP), Centre de recherche en épidémiologie et santé des populations (CESP), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Université Paris-Sud - Paris 11 (UP11)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Versailles Saint-Quentin-en-Yvelines (UVSQ), ClinSearch [Malakoff, France], Luxembourg Institute of Health (LIH), Integrated BioBank of Luxembourg (IBBL), Université de Paris - UFR Médecine Paris Centre [Santé] (UP Médecine Paris Centre), Université de Paris (UP), Infrastructures en Biologie Santé et Agronomie, IBiSA: ANR-11-INBS-0002 H. Lundbeck A/S AstraZeneca France MSD France, The Constances Cohort Study was supported and funded by the Caisse nationale d’assurance maladie (CNAM). The Constances Cohort Study is an Infrastructure nationale en Biologie et Santé and benefits from a grant from ANR (ANR-11-INBS-0002) and from the Ministry of Research. Constances is also partly funded by MSD, AstraZeneca and Lundbeck., ANR-11-INBS-0002,CONSTANCES,La cohorte CONSTANCES - Infrastructure épidémiologique ouverte pour la recherche et la surveillance(2011), HAL UVSQ, Équipe, Infrastructures - La cohorte CONSTANCES - Infrastructure épidémiologique ouverte pour la recherche et la surveillance - - CONSTANCES2011 - ANR-11-INBS-0002 - INBS - VALID, Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris-Saclay-Université Paris Cité (UPCité), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Université Paris-Sud - Paris 11 (UP11)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Paul Brousse-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Cité - UFR Médecine [Santé] (UPCité UFR Médecine), and Université Paris Cité (UPCité)
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biobanking methodology ,[SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie ,urine samples ,blood samples ,longitudinal studies ,[SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie ,DNA ,population-based cohort ,biorepository ,observational studies - Abstract
International audience; “General-purpose cohorts” in epidemiology and public health are designed to cover a broad scope of determinants and outcomes, in order to answer several research questions, including those not defined at study inception. In this context, the general objective of the CONSTANCES project is to set up a large population-based cohort that will contribute to the development of epidemiological research by hosting ancillary projects on a wide range of scientific domains, and to provide public health information. CONSTANCES was designed as a randomly selected sample of French adults aged 18–69 years at study inception; 202,045 subjects were included over an 8-year period. At inclusion, the selected participants are invited to attend one of the 24 participating Health Prevention Centers (HPCs) for a comprehensive health examination. The follow-up includes a yearly self-administered questionnaire, and a periodic visit to an HPC. Procedures have been developed to use the national healthcare databases to allow identification and validation of diseases over the follow-up. The biological collection (serum, lithium heparinized plasma, EDTA plasma, urine and buffy coat) began gradually in June 2018. At the end of the inclusions, specimens from 83,000 donors will have been collected. Specimens are collected according to a standardized protocol, identical in all recruitment centers. All operations relating to bio-banking have been entrusted by Inserm to the Integrated Biobank of Luxembourg (IBBL). A quality management system has been put in place. Particular attention has been paid to the traceability of all operations. The nature of the biological samples stored has been deliberately limited due to the economic and organizational constraints of the inclusion centers. Some research works may require specific collection conditions, and can be developed on request for a limited number of subjects and in specially trained centers. The biological specimens that are collected will allow for a large spectrum of biomarkers studies and genetic and epigenetic markers through candidate or agnostic approaches. By linking the extensive data on personal, lifestyle, environmental, occupational and social factors with the biomarker data, the CONSTANCES cohort offers the opportunity to study the interplays between these factors using an integrative approach and state-of-the-art methods.
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- 2020
18. Indications and outcomes of antifungal therapy in French patients with haematological conditions or recipients of haematopoietic stem cell transplantation
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Herbrecht, Raoul, Caillot, Denis, Cordonnier, Catherine, Auvrignon, Anne, Thiébaut, Anne, Brethon, Benoît, Michallet, Mauricette, Mahlaoui, Nizar, Bertrand, Yves, Preziosi, Paul, Ruiz, Fabrice, Gorin, Norbert-Claude, and Gangneux, Jean-Pierre
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- 2012
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19. Burden of infantile hemangioma: Development of a questionnaire
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Taieb, Charles, Ruiz, Fabrice, and Voisard, Jean Jacques
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- 2012
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20. Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid-based cytology in primary cervical cancer screening: The FASE study†
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Monsonego, Joseph, Hudgens, Michael G., Zerat, Laurent, Zerat, Jean-Claude, Syrjänen, Kari, Halfon, Philippe, Ruiz, Fabrice, and Smith, Jennifer S.
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- 2011
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21. Medicine acceptability for older people in hospital and care home: the influence of setting.
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Jani, Yogini H, Liu, Fang, Orlu, Mine, Desai, Neel, Chayla, Florence du, Ruiz, Fabrice, and Vallet, Thibault
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Objective Medicines acceptability is likely to have a significant impact on older people's adherence and, consequently, treatment effectiveness. The objective was to explore the influence of setting on medicines acceptability in older people. Methods A multi-centre, prospective, cross-sectional, observational study was conducted in one care home and one elderly care hospital ward in London, UK, involving individuals on ≥1 medicine(s) and aged ≥65 years. Data-driven approach was applied using multiple observer-reported outcomes analysis tool to distinguish between positively and negatively accepted medicines. Key findings 263 observer reports from the care home (n = 97) and hospital ward (n = 166) involving 155 distinct medicinal products were assessed. Collectively, medicines appeared better accepted by patients at the hospital. Differences appeared to be driven by variations in solid oral dosage form (SODF) acceptability. Patients with dysphagia poorly accepted medicines in both settings, as expected. SODFs were unexpectedly better accepted in the hospital than in the care home in patients without dysphagia. Conclusions Medicines acceptability was affected by patient's characteristics, dosage form type and setting. Changes in care practices between care home and hospital may affect medicine administration and lead to variations in the ability and willingness of patients and carers to use the product as intended. [ABSTRACT FROM AUTHOR]
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- 2022
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22. Dosage form suitability in vulnerable populations: A focus on paracetamol acceptability from infants to centenarians.
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Ruiz, Fabrice, Vallet, Thibault, Dufaÿ Wojcicki, Amélie, Belissa, Émilie, Fontan, Jean-Eudes, de Pontual, Loïc, Nathanson, Sylvie, Chevallier, Alain, Laribe-Caget, Sandra, and Boudy, Vincent
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Introduction: Medicine acceptability is a multi-faceted concept driven by both product and user characteristics. Although a key factor for treatment effectiveness, especially in vulnerable populations, knowledge of those medicine features that best promote individual user acceptability remains fragmented. Focusing on paracetamol, this study has explored the appropriateness of pharmaceutical products in different dosage forms to achieve adequate patient acceptability from infants to centenarians. Methods: This observational, multicentre, prospective study was carried out in 10 hospitals, 8 nursing homes and over 150 community dispensaries. Observers reported several behaviours/events evaluating acceptability for 1016 different pharmaceutical product uses in paediatrics (<18y.) and 1288 in the elderly (≥65y.). Using mapping and clustering, a multivariate approach offered an intelligible reference framework for each population, providing comprehensive scores: positively or negatively accepted. Results: Among all the evaluations supporting the acceptability reference frameworks, there were 502 reports on paracetamol products intake. Herein we focused on the 5 products with ≥30 evaluations. Although oral suspension and powder for oral solution were positively-accepted in the paediatric group, the powder had a higher rate of negative patient reaction (p<0.001). Of those that received this formulation, 72% were ≤8y., and therefore suitable to receive the better accepted oral suspension. In the elderly, patients with swallowing disorders were preferentially treated with such powders (p<0.001), which were less often fully taken than orally disintegrating tablets (p<0.001). Even in those patients ≥90y., capsule formulations appeared to be the best accepted product in patients without swallowing alterations, and thus could be a suitable alternative to the powder in this population. Conclusions: By better integrating patient characteristics when choosing dosage forms, clinicians and caregivers may improve treatment acceptability and adherence. Moreover, hospitals and healthcare institutions could optimise purchasing to best suit their local population, disseminating information to help staff align specific dosage forms to targeted patients. [ABSTRACT FROM AUTHOR]
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- 2019
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23. Anticholinergic drug use and cognitive performances in middle age: findings from the CONSTANCES cohort.
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Ziad, Abdelkrim, Olekhnovitch, Romain, Ruiz, Fabrice, Berr, Claudine, Bégaud, Bernard, Goldberg, Marcel, Zins, Marie, and Mura, Thibault
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PARASYMPATHOLYTIC agents ,COGNITIVE ability ,COGNITION in old age ,PHARMACODYNAMICS ,VERBAL memory ,EXECUTIVE function ,COGNITION ,COMPARATIVE studies ,LANGUAGE & languages ,NEUROPSYCHOLOGICAL tests ,RESEARCH methodology ,MEDICAL cooperation ,MEMORY ,PARASYMPATHOMIMETIC agents ,RESEARCH ,EVALUATION research ,CROSS-sectional method - Abstract
Background: Previous studies have shown associations between the use of anticholinergics (AC) and cognitive performance in the elderly, considering AC as a homogeneous set of drugs. The present study aims to assess the relationship between exposure to AC drugs and cognitive performance in middle-aged adults according to AC potency and drug class.Methods: Our cross-sectional study used baseline data of 34 267 participants aged 45-70 from the Consultants des centres d'examen de santé de la sécurité sociale (CONSTANCES) cohort. The cumulative exposure to AC was measured using national reimbursement databases over the 3-year period preceding assessment of cognitive performance. Eight classes of AC drugs were differentiated. Episodic verbal memory, language abilities and executive functions were evaluated by validated neuropsychological tests. Analyses were controlled on lifestyle and health status variables.Results: This study showed a negative association between overall cumulative AC exposure and cognitive performances after adjustment. The use of drugs with possible AC effect according to the Anticholinergic Cognitive Burden scale (ACB-1 score) was only associated with executive functions. Analyses of AC exposure across drug classes showed a negative association between the use of AC antipsychotics and all cognitive functions assessed. Heterogeneous associations were found for the use of AC anxiolytics, AC opioids and AC drugs targeting the gastrointestinal tract or metabolism. We did not find significant associations between the use of antihistamines, antidepressants, cardiovascular system or other AC medications and cognitive function.Conclusion: Association between AC drugs and cognitive performance was highly heterogeneous across drug classes; this heterogeneity will have to be considered by future studies. [ABSTRACT FROM AUTHOR]- Published
- 2018
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24. Standardized method to assess medicines' acceptability: focus on paediatric population.
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Ruiz, Fabrice, Vallet, Thibault, Pensé‐Lhéritier, Anne‐Marie, and Aoussat, Ameziane
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DRUG formularies , *CHILD health services , *DRUG administration , *MULTIPLE correspondence analysis (Statistics) , *MEDICAL needs assessment - Abstract
Objectives The purpose of this article was to present an original standardized tool assessing the medicine's acceptability whichever their characteristics and the patient features. Methods An acceptability map was built with objective measures from medicine use assessments collected in real-life conditions. Multiple correspondence analysis ( MCA) was used for the mapping process. Hierarchical classification on the principal components ( HCPC) of the MCA was performed for the clustering process corresponding to distinct acceptability profiles. Key findings The results presented here focus on 234 evaluations issued from the paediatric population and gathered in four clusters: 'well-accepted' (50%), 'accepted' (19%), 'poorly accepted' (25%) and 'not accepted' medicines (6%). The first one was characterized by a dose fully taken, in a short time, with a patient's positive reaction; the second by a longer administration time, a neutral reaction and the use of methods to achieve administration (reward, divided dose). Differentiation between the two last clusters was, respectively, originated by a required dose partially taken or not taken. Conclusions The acceptability profile of each medicine can be evaluated with the map position of the related patient's assessments barycentre. This tool should satisfy expectations in terms of methods for appropriate acceptability evaluation and standardized comparison among medicines. [ABSTRACT FROM AUTHOR]
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- 2017
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25. Preliminary development of a tool assessing the acceptability of medicines for paediatric use
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Vallet, Thibault, Ruiz, Fabrice, Tadmouri, Abir, Blomkvist, Josefin, Pense-Lheritier, Anne-Marie, and Aoussat, Améziane
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- 2016
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26. High quality standards for a large-scale prospective population-based observational cohort: Constances.
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Ruiz, Fabrice, Goldberg, Marcel, Lemonnier, Sylvie, Ozguler, Anna, Boos, Evelyne, Brigand, Alain, Giraud, Violaine, Perez, Thierry, Roche, Nicolas, and Zins, Marie
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QUALITY standards , *LONGITUDINAL method , *COHORT analysis , *ACQUISITION of data , *STATISTICAL reliability , *PARTICIPANT observation , *COMPUTER science , *DATABASES , *INFORMATION science , *PUBLIC health surveillance , *QUALITY control - Abstract
Background: Long-term multicentre studies are subject to numerous factors that may affect the integrity of their conclusions. Quality control and standardization of data collection are crucial to minimise the biases induced by these factors. Nevertheless, tools implemented to manage biases are rarely described in publications about population-based cohorts. This report aims to describe the processes implemented to control biases in the Constances cohort taking lung function results as an example.Methods: Constances is a general-purpose population-based cohort of 200,000 participants. Volunteers attend physical examinations at baseline and then every 5 years at selected study sites. Medical device specifications and measurement methods have to comply with Standard Operating Procedures developed by experts. Protocol deviations are assessed by on-site inspections and database controls. In February 2016, more than 94,000 participants yielding around 30 million readings from physical exams, had been covered by our quality program.Results: Participating centres accepted to revise their practices in accordance with the study research specifications. Distributors of medical devices were asked to comply with international guidelines and Constances requirements. Close monitoring enhanced the quality of measurements and recordings of the physical exams. Regarding lung function testing, spirometry acceptability rates per operator doubled in some sites within a few months and global repeatability reached 96.7 % for 29,772 acceptable maneuvers.Conclusions: Despite Constances volunteers being followed in multiple sites with heterogeneous materials, the investment of significant resources to set up and maintain a continuous quality management process has proved effective in preventing drifts and improving accuracy of collected data. [ABSTRACT FROM AUTHOR]- Published
- 2016
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27. Dosage Forms Suitability in Pediatrics: Acceptability of Analgesics and Antipyretics in a German Hospital.
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Klingmann, Viviane, Vallet, Thibault, Münch, Juliane, Stegemann, Robin, Wolters, Lena, Bosse, Hans-Martin, and Ruiz, Fabrice
- Subjects
ANTIPYRETICS ,MEDICAL personnel ,ANALGESICS ,CHILDREN'S hospitals ,PATIENT compliance ,OPIOID analgesics - Abstract
Although medicine acceptability is likely to have a significant impact on the patient's adherence in pediatrics and therefore on therapy success, there is still little data even for common therapeutic areas. For analgesics/antipyretics, healthcare professionals face a wide variety of products and need knowledge to select the best adapted product for each patient. We investigated acceptability of those products most used at the University Children's Hospital Düsseldorf, Germany. Based on 180 real-life observer reports of medicine intake, we used the acceptability reference framework to score acceptability of six distinct medicines. Both ibuprofen and paracetamol tablets, mainly used in adolescents, were positively accepted. This was not the case for the solution for injection of metamizole sodium. Regarding syrups, mainly used in children under 6 years of age, ibuprofen flavored with strawberry and provided with an oral syringe was positively accepted, while paracetamol flavored with orange and provided with a measuring cup was not. Suppository appeared to be an alternative to oral liquids in infants and toddlers with palatability and administration issues. Differences appeared to be driven by dosage forms and formulations. These findings improve knowledge on acceptability drivers and might help formulating and prescribing better medicines for children. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
28. Acceptability of Mebendazole Chewable Tablet in Children Aged 2 to 4 Years in Peru.
- Author
-
Perez, Fernando, Vallet, Thibault, Bravo, Zarela, Callahan, Kristin, and Ruiz, Fabrice
- Subjects
PARASITIC diseases ,TREATMENT effectiveness ,HELMINTHIASIS - Abstract
Soil-transmitted helminthiasis (STH) is among the most common of parasitic infections, affecting vulnerable populations in tropical/subtropical areas globally. In endemic countries, children, a high-risk population, require treatment and preventive interventions. Mebendazole, a WHO-recommended medicine, originally formulated as a tablet that was often crushed for administration to young children unable to swallow it, was reformulated as a chewable tablet. Acceptability is a key aspect for treatment effectiveness in pediatrics. Herein, we used a validated data-driven approach to investigate the acceptability of the 500-mg mebendazole chewable tablet in children aged 2 to 4 years in Peru. Observer-reported outcomes were collected for 182 medicine intakes. Acceptability was scored using the acceptability reference framework: a three-dimensional map juxtaposing "positively accepted" and "negatively accepted" profiles. Results found that the 500-mg mebendazole chewable tablet was classified as "positively accepted" in children aged 2 to 4 years. Acceptability increased with age and some acceptability issue remain for the younger children. Nevertheless, this formulation was considerably better accepted than the conventional tablets regardless of treatment in young children. This chewable formulation appears to be an appropriate alternative to the hard tablet of mebendazole for treatment of STH and preventive interventions in children aged 2 to 4 years. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
29. Exploring Acceptability Drivers of Oral Antibiotics in Children: Findings from an International Observational Study.
- Author
-
Vallet, Thibault, Bensouda, Yahya, Saito, Jumpei, Mathiesen, Liv, Pokharkar, Varsha, Klingmann, Viviane, Peak, Matthew, Elhamdaoui, Omar, Yamatani, Akimasa, Ivanovic, Ivana, Sajith, Manjusha, Münch, Juliane, Bracken, Louise, Duncan, Jennifer Claire, Salunke, Smita, Wang, Siri, and Ruiz, Fabrice
- Subjects
ANTIBIOTICS ,SCIENTIFIC observation ,PATIENT compliance ,WORLD health ,PRESCHOOL children ,TODDLERS ,EXCIPIENTS - Abstract
Antibiotics are among the most commonly prescribed drugs in children. Adherence to the treatment with these drugs is of the utmost importance to prevent the emergence of resistant bacteria, a global health threat. In children, medicine acceptability is likely to have a significant impact on compliance. Herein we used a multivariate approach, considering simultaneously the many aspects of acceptability to explore the drivers of oral antibiotic acceptability in children under twelve, especially in toddlers and in preschoolers. Based on 628 real-life observer reports of the intake of 133 distinct medicines, the acceptability reference framework highlighted the influence of many factors such as age and sex of patients, previous exposure to treatment, place of administration, administration device, flavor agent in excipients and active pharmaceutical ingredient. These findings from an international observational study emphasize the multidimensional nature of acceptability. Therefore, it is crucial to consider all these different aspects for assessing this multi-faceted concept and designing or prescribing a medicine in order to reach adequate acceptability in the target population. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF
30. Adherence and Acceptability of an Oral Antibiotic Used for the Prevention of Pediatric Urinary Tract Infection in Japan.
- Author
-
Saito, Jumpei, Miyamoto, Sayaka, Yamada, Mayumi, Yamatani, Akimasa, Ruiz, Fabrice, Vallet, Thibault, Fariña, José B., and Bergonzi, Maria Camilla
- Subjects
URINARY tract infections ,CATHETER-associated urinary tract infections ,PATIENT compliance ,DRUG efficacy ,ANTIBIOTICS ,UROLOGICAL surgery - Abstract
Urinary tract infection (UTI) is a common health care-associated adverse event and the leading nosocomial complication following pediatric urological surgery. While continuous antimicrobial prophylaxis effectively reduces the risk of UTI following such a surgery, non-adherence is common and represents a distinct clinical entity that is associated with renal scarring. Acceptability is likely to have a significant impact on patient adherence. Herein we used a validated data-driven approach—the ClinSearch acceptability score test (CAST)—to investigate the acceptability of cefaclor, an oral antibiotic widely used for the prevention of pediatric UTI in Japan. Standardized observer reports were collected for 58 intakes of cefaclor 10% fine granules in patients aged from 0 to 17 years. The medicine was classified as positively accepted on the acceptability reference framework. According to the percentage of the prescribed dose taken reported at the end of the treatment, patients exhibited good adherence to this well-accepted medicine. Nonetheless, requirements for greater dosing frequency or poor acceptability in certain patients could affect adherence. Acceptability should be established to ensure patient adherence to medicines used for long-term prophylaxis and consequently guarantee the safety and efficacy of the treatment. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF
31. Acceptability of a Sublingual Drug Formulation for Respiratory Tract Infections in Children Aged 3 to 5 Years.
- Author
-
Emeryk, Andrzej, Vallet, Thibault, Wawryk-Gawda, Ewelina, Jędrzejewski, Arkadiusz, Durmont, Frederic, Ruiz, Fabrice, and Fariña, José B.
- Subjects
RESPIRATORY infections in children ,RESPIRATORY infections ,RESPIRATORY agents ,DRUG efficacy ,PRESCHOOL children - Abstract
In pediatrics, acceptability has emerged as a key factor for compliance, and consequently for treatment safety and efficacy. Polyvalent mechanical bacterial lysate (PMBL) in 50-mg sublingual tablets is indicated in children and adults for the prophylaxis of recurrent respiratory tract infections. This medication may be prescribed in children over 3 years of age; the appropriateness of this sublingual formulation should thus be demonstrated amongst young children. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for medication intake over the course of treatment (days 1, 2, and 10) in 37 patients aged 3 to 5 years, and then analyzed in an intelligible model: the acceptability reference framework. According to this multidimensional model, 50-mg PMBL sublingual tablets were classified as "positively accepted" in children aged 3 to 5 years on all three days of evaluation. As the acceptability evaluation should be relative, we demonstrated that there was no significant difference between the acceptability of these sublingual tablets and a score reflecting the average acceptability of oral/buccal medicines in preschoolers. These results highlight that sublingual formulations could be appropriate for use in preschoolers. [ABSTRACT FROM AUTHOR]
- Published
- 2021
- Full Text
- View/download PDF
32. Medicines Acceptability in Hospitalized Children: An Ongoing Need for Age-Appropriate Formulations.
- Author
-
Vallet, Thibault, Elhamdaoui, Omar, Berraho, Amina, Cherkaoui, Lalla Ouafae, Kriouile, Yamna, Mahraoui, Chafiq, Mouane, Nezha, Pense-Lheritier, Anne-Marie, Ruiz, Fabrice, and Bensouda, Yahya
- Subjects
HOSPITAL care of children ,TODDLERS ,PRESCHOOL children ,DRUGS - Abstract
Although knowledge on medicine acceptability remains fragmented, this multi-faceted concept has emerged as a key factor for compliance in pediatrics. In order to investigate the acceptability of medicines used in the University Medical Centre Ibn Sina (CHIS) of Rabat, Morocco, an observational study was conducted. Using a multivariate approach integrating the many aspects of acceptability, standardized observer reports were collected for 570 medicine intakes in patients up to the age of 16, then analyzed on a reference framework. Tablets appeared to be well accepted in children greater than 6 years old, but were crushed/dissolved for 90% of the 40 children aged from 3 to 5, and 100% of the 38 patients younger than 3. Moreover, the prescribed dose was fully taken for only 52% and 16% of these younger children, respectively. Despite this, tablets represented 24% of evaluations in children from 3 to 5 and 20% in infants and toddlers. Oral liquid preparations appeared to be better accepted than tablets in preschoolers, but not for those under 3. Overall, these findings highlight the lack of suitable alternatives for the younger children, especially for formulations of antiepileptics, antithrombotic, and psycholeptic agents in the local context. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
33. Acceptability in the Older Population: The Importance of an Appropriate Tablet Size.
- Author
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Vallet, Thibault, Michelon, Hugues, Orlu, Mine, Jani, Yogini, Leglise, Patrick, Laribe-Caget, Sandra, Piccoli, Matthieu, Le Fur, Aurélie, Liu, Fang, Ruiz, Fabrice, and Boudy, Vincent
- Subjects
SOLID dosage forms ,OLDER patients ,OLDER people - Abstract
Presenting many advantages, solid oral dosage forms (SODFs) are widely manufactured and frequently prescribed in older populations regardless of the specific characteristics of patients. Commonly, patients with dysphagia (swallowing disorders) experience difficulties taking SODFs, which may lead to non-adherence or misuse. SODF characteristics (e.g., size, shape, thickness) are likely to influence swallowability. Herein, we used the acceptability reference framework (the ClinSearch acceptability score test (CAST))—a 3D-map juxtaposing two acceptability profiles—to investigate the impact of tablet size on acceptability. We collected 938 observer reports on the tablet intake by patients ≥65 years in hospitals or care homes. As we might expect, tablets could be classified as accepted in older patients without dysphagia (n = 790), while not in those with swallowing disorders (n = 146). However, reducing the tablet size had a significant impact on acceptability in this subpopulation: tablets <6.5 mm appeared to be accepted by patients with swallowing disorders. Among the 309 distinct tablets assessed in this study, ranging in size from 4.7 to 21.5 mm, 83% are ≥6.5 mm and consequently may be poorly accepted by institutionalized older people and older inpatients suffering from dysphagia. This underlines the need to develop and prescribe medicines with the best adapted characteristics to reach an optimal acceptability in targeted users. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
34. Sex Differences in Medicine Acceptability: A New Factor to Be Considered in Medicine Formulation.
- Author
-
Ruiz, Fabrice, Keeley, Alexander, Léglise, Patrick, Tuleu, Catherine, Lachuer, Célia, Rwabihama, Jean-Paul, Bachalat, Nathalie, Boulaich, Imad, Abdallah, Fattima, Rabus, Maité, Ribemont, Annie-Claude, Michelon, Hugues, Wojcicki, Amélie Dufaÿ, Orlu, Mine, Vallet, Thibault, and Boudy, Vincent
- Subjects
- *
GENDER , *DRUG development , *DRUGS , *AVERSION , *ANIMAL models in research - Abstract
Palatability is a recognized driver of medicine acceptability in pediatrics but deemed less relevant in older populations due to sensory decline. Preliminary findings from an observational study implicated palatability problems with one Alzheimer's medicine. Among 1517 observer reports combining multiple measures on medicines uses in patients aged over 64, we focused on two original formulations of memantine (Ebixa®, tablets (n = 25) and oral solution (n = 60)). Evaluations were scored with an acceptability reference framework (CAST), the rodent Brief Access Taste Aversion (BATA) model tested aversiveness. Focusing on women treated with Ebixa® (n = 54), the oral formulation sub-group was classified as "negatively accepted", while the coated tablet was associated with the "positively accepted" cluster. In men, both formulations belonged to the "positively accepted" profile. Using BATA, the original oral solution was categorized as highly aversive/untolerated while solutions of excipients only were well tolerated. Furthermore, the number of licks was significantly lower in female than in male rats. These results revealed that medicine palatability remains important for acceptability in older populations. Moreover, converging results from humans and animal models highlighted that palatability profiles can significantly vary between the sexes. These drivers should be closely considered during drug development to enhance acceptability in this population. [ABSTRACT FROM AUTHOR]
- Published
- 2019
- Full Text
- View/download PDF
35. Explorations of factors affecting medicine acceptability using standardized evaluations.
- Author
-
Vallet, Thibault, Ruiz, Fabrice, Pense-Lheritier, Anne-Marie, and Aoussat, Améziane
- Subjects
- *
PEDIATRICS , *DRUG therapy - Published
- 2018
- Full Text
- View/download PDF
36. Rational and practical considerations to guide a target product profile for patient-centric drug product development with measurable patient outcomes – A proposed roadmap.
- Author
-
Stegemann, Sven, Sheehan, Liz, Rossi, Alessandra, Barrett, Andrew, Paudel, Amrit, Crean, Abina, Ruiz, Fabrice, Bresciani, Massimo, Liu, Fang, Shariff, Zakia, Shine, Margarete, Schmelzer, Christel, and Pense-Lheritier, Anne-Marie
- Subjects
- *
DRUG development , *NEW product development , *DRUG design , *COMPLEX matrices , *PATIENTS' attitudes - Abstract
[Display omitted] The increasing awareness of acceptability and usability of pharmaceutical drug products by the patient as a key quality requirement continues to drive need for integrating patient centric drug product design into the pharmaceutical development process. The complex matrix of multiple drug product related decisions during the early drug development process often limits patient-centric drug product (PCDP) design options in the final commercial drug product development phase. To integrate the specific needs and perspectives of patients into drug development and product design process, a rational approach integrated into the complex development matrix is required from the start and weighs product development decision options accordingly. The aim of this work was to develop a roadmap for PCDP design in a multidisciplinary approach that leads to better usability, adherence and acceptance of the drug by patients via early integration into the development matrix. The proposed rational approach is based upon regulatory requirements and lessons learned from pediatric and geriatric drug development. [ABSTRACT FROM AUTHOR]
- Published
- 2022
- Full Text
- View/download PDF
37. Acceptability of Mebendazole Chewable Tablet in Children Aged 2 to 4 Years in Peru.
- Author
-
Perez F, Vallet T, Bravo Z, Callahan K, and Ruiz F
- Abstract
Soil-transmitted helminthiasis (STH) is among the most common of parasitic infections, affecting vulnerable populations in tropical/subtropical areas globally. In endemic countries, children, a high-risk population, require treatment and preventive interventions. Mebendazole, a WHO-recommended medicine, originally formulated as a tablet that was often crushed for administration to young children unable to swallow it, was reformulated as a chewable tablet. Acceptability is a key aspect for treatment effectiveness in pediatrics. Herein, we used a validated data-driven approach to investigate the acceptability of the 500-mg mebendazole chewable tablet in children aged 2 to 4 years in Peru. Observer-reported outcomes were collected for 182 medicine intakes. Acceptability was scored using the acceptability reference framework: a three-dimensional map juxtaposing "positively accepted" and "negatively accepted" profiles. Results found that the 500-mg mebendazole chewable tablet was classified as "positively accepted" in children aged 2 to 4 years. Acceptability increased with age and some acceptability issue remain for the younger children. Nevertheless, this formulation was considerably better accepted than the conventional tablets regardless of treatment in young children. This chewable formulation appears to be an appropriate alternative to the hard tablet of mebendazole for treatment of STH and preventive interventions in children aged 2 to 4 years.
- Published
- 2021
- Full Text
- View/download PDF
38. Acceptability of oral liquid pharmaceutical products in older adults: palatability and swallowability issues.
- Author
-
Belissa E, Vallet T, Laribe-Caget S, Chevallier A, Chedhomme FX, Abdallah F, Bachalat N, Belbachir SA, Boulaich I, Bloch V, Delahaye A, Depoisson M, Wojcicki AD, Gibaud S, Grancher AS, Guinot C, Lachuer C, Lechowski L, Leglise P, Mahiou A, Meaume S, Michel C, Michelon H, Orven Y, Perquy I, Piccoli M, Rabus M, Ribemont AC, Rwabihama JP, Trouvin JH, Ruiz F, and Boudy V
- Subjects
- Administration, Oral, Aged, Aged, 80 and over, Female, Humans, Male, Nursing Homes, Prospective Studies, Sex Factors, Taste, Deglutition physiology, Deglutition Disorders physiopathology, Patient Compliance, Pharmaceutical Preparations administration & dosage
- Abstract
Background: In institutional care, oral liquid pharmaceutical products are widely prescribed for older patients, especially for those with swallowing disorders. As medicines acceptability is a key factor for compliance in the older population, this study investigated the acceptability of oral liquid pharmaceutical products in this targeted population., Methods: An observational, multicenter, prospective study was conducted in eight geriatric hospitals and eight nursing homes in France. Observers reported several behaviours/events describing the many aspects of acceptability for various pharmaceutical products' uses in patients aged 65 and older. Acceptability scores of oral liquid pharmaceutical products were obtained using an acceptability reference framework (CAST - ClinSearch Acceptability Score Test®): a 3D-map summarizing the different users' behaviors, with two clusters defining the positively and negatively accepted profiles materialized by the green and red zones, respectively., Results: Among 1288 patients included in the core study and supporting the acceptability reference framework, 340 assessments were related to the administration of an oral liquid pharmaceutical product. The mean age of these patients was 87 (Range [66-104y]; SD = 6.7), 68% were women and 16% had swallowing disorders. Globally, the oral liquid pharmaceutical products were classified as "positively accepted," the barycenter of the 340 assessments, along with the entire confidence ellipses surrounding it, were positioned on the green zone of the map. Sub-populations presenting a different acceptability profile have also been identified. For patients with swallowing disorders, the oral liquid pharmaceutical products were classified as "negatively accepted," the barycenter of the 53 assessments along with 87% of its confidence ellipses were associated with this profile. A gender difference was observed for unflavored oral liquids. In women, they were classified "negatively accepted," the barycenter of the 68 assessments with 75% of its confidence ellipses were located in the red zone, while they were classified "positively accepted" in men., Conclusion: This study showed that oral liquid pharmaceutical products are a suboptimal alternative to solid oral dosage forms in patients with swallowing disorders. To ensure an optimal acceptability, prescribers should also consider the presence of a taste-masker in these oral liquids. As highlighted herein, palatability remains crucial in older populations, especially for women.
- Published
- 2019
- Full Text
- View/download PDF
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