15 results on '"Alharf, Adel"'
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2. National medicines policy development, Saudi Arabia/[phrase omitted]/[phrase omitted]/ Elaboration des politiques pharmaceutiques nationales en Arabie saoudite/[phrase omitted]/ Desarrollo de la politica nacional de medicamentos en Arabia Saudita
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Almoteiry, Khalid, Alharf, Adel, Hammad, Bandar Al, Aljuffali, Ibrahim, Azemi, Nahar Al-, Ghaith, Taghred Al-, Alhomidi, Shahad, Alshehri, Ahlam, Seiter, Andreas, Herbst, Christopher, and Pisani, Elizabeth
- Subjects
Drugs ,Pharmaceutical policy ,Pharmaceutical industry ,Health ,World Health Organization -- Economic policy - Abstract
Medicines are at the core of every health system. The World Health Organization recommends countries develop national medicines policies that guide production, procurement, prescription and provision of medicines so that people can access the medicines they need at prices they can afford, while avoiding irrational use. However, the development of such policies is rarely straightforward. We describe important components of the national medicines policy in Saudi Arabia, which was developed within a broader transformation of the health system and the economy. The new policy formalizes existing best practices, shapes emerging policies and sets a direction for future development in four main areas. First, the policy seeks to consolidate institutional roles to provide greater cohesion; second it aims to reshape procurement and prescribing habits, with a greater focus on cost containment; third, it lays out policies which focus on assuring a secure supply of good-quality medicines, including essential medicines with limited profit potential and new products. Finally, the policy supports the growth of the domestic pharmaceutical industry, including the development of human resources. Many sectors and institutions joined in the development of the medicines policy, which was underpinned by a review of the past and current pharmaceutical context in Saudi Arabia, and good practices globally. The resulting policy was built on evidence and endeavours to give clear direction to the pharmaceutical industry and implementing agencies on rules and requirements, professional norms and institutional roles. At the same time, it maintains flexibility to allow for adaptation in a rapidly evolving institutional landscape. [phrase omitted] [phrase omitted] Les medicaments sont au creur de tout systeme de sante. LOrganisation mondiale de la Sante recommande aux pays d'elaborer des politiques pharmaceutiques nationales qui determinent la production, l'obtention, la prescription et la fourniture de medicaments, afin que la population puisse acceder aux traitements requis a un prix abordable sans toutefois tomber dans un usage irrationnel. Mais cette elaboration est rarement simple. Dans le present document, nous abordons les principaux aspects de la politique pharmaceutique nationale en Arabie saoudite, developpee dans le cadre d'une vaste transformation de l'economie et du systeme de sante. Cette nouvelle politique officialise les bonnes pratiques existantes, faconne les projets emergents et definit une orientation pour l'evolution future dans quatre domaines cles. Premierement, elle cherche a renforcer le role des institutions pour ameliorer la cohesion. Deuxiemement, elle vise a remanier les habitudes d'obtention et de prescription, en se focalisant sur la maitrise des couts. Troisiemement, elle etablit des mesures destinees a assurer un approvisionnement sur en medicaments de qualite, y compris en nouveaux produits et medicaments essentiels au potentiel de rentabilite limite. Et quatriemement, elle soutlent la crolssance de l'industrie pharmaceutique dans le pays, notamment le developpement des ressources humaines. De nombreux secteurs et institutions ont contribue a l'elaboration de cette politique, qui s'appuie sur une analyse du contexte pharmaceutique anterieur et actuel en Arabie saoudite ainsi que sur les bonnes pratiques mondiales. Le resultat repose sur des elements et efforts tangibles. Il montre clairement a l'industrie pharmaceutique et aux organismes de mise en reuvre la marche a suivre en matiere de regles et d'exigences, de normes professionnelles et de roles institutionnels. Et dans le meme temps, il prevoit suffisamment de flexibilite pour s'adapter a un paysage institutionnel en constante mutation. [phrase omitted] Los medicamentos son el nucleo de todo el sistema sanitario. La Organizacion Mundial de la Salud recomienda a los paises que desarrollen politicas nacionales de medicamentos que guien la produccion, la adquisicion, la prescripcion y el suministro de estos, de modo que las personas puedan acceder a los medicamentos que necesitan a precios que puedan pagar, evitando al mismo tiempo un uso irracional. Sin embargo, la elaboracion de estas politicas no suele ser sencilla. En este documento se describen componentes importantes de la politica nacional de medicamentos en Arabia Saudita, que se desarrollo en el marco de una transformacion mas amplia del sistema sanitario y la economia. La nueva politica formaliza las mejores practicas existentes, da forma a las politicas emergentes y establece una direccion para el desarrollo futuro en cuatro areas principales. En primer lugar, la politica busca consolidar las funciones institucionales para proporcionar una mayor cohesion; en segundo lugar, pretende remodelar los habitos de adquisicion y prescripcion, centrandose mas en la contencion de los costes; en tercer lugar, establece politicas que se centran en asegurar el suministro de medicamentos de buena calidad, incluidos los productos nuevos y los medicamentos esenciales con un potencial de beneficio limitado. Por ultimo, la politica apoya el crecimiento de la industria farmaceutica nacional, incluido el desarrollo de los recursos humanos. Varios sectores e instituciones participaron en la elaboracion de la politica de medicamentos, que se sustento en una revision del contexto farmaceutico pasado y actual en Arabia Saudita, y de las buenas practicas a nivel mundial. La politica resultante se creo a partir de pruebas y se esfuerza por dar una orientacion clara a la industria farmaceutica y a los organismos de ejecucion sobre las reglas y requisitos, las normas profesionales y las funciones institucionales. Asimismo, mantiene la flexibilidad para permitir la adaptacion en un panorama institucional que evoluciona muy rapido., Introduction Pharmaceuticals--medicines, vaccines and diagnostic tests--and medical equipment are at the centre of any health system, and are central to good clinical practice. The World Health Organization (WHO) recommends that [...]
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- 2022
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3. Hospitalization Endpoint in Clinical Trials of Outpatient Settings: using Anti-SARS-COV-2 Therapy as an Example
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Alnafisah, Alhanouf, primary, Alkhalidi, Ahmed, additional, Aljohani, Hanin, additional, Almutairi, Manal, additional, Alharf, Adel, additional, and Alkofide, Hadeel, additional
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- 2024
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4. Hospitalization Endpoint in Clinical Trials of Outpatient Settings: using Anti-SARS-COV-2 Therapy as an Example
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Alnafisah,Alhanouf, Alkhalidi,Ahmed, Aljohani,Hanin, Almutairi,Manal, Alharf,Adel, Alkofide,Hadeel, Alnafisah,Alhanouf, Alkhalidi,Ahmed, Aljohani,Hanin, Almutairi,Manal, Alharf,Adel, and Alkofide,Hadeel
- Abstract
Alhanouf Yousef Alnafisah,1 Ahmed Fawaz Alkhalidi,1 Hanin Aljohani,1 Manal Almutairi,1 Adel Alharf,2 Hadeel Alkofide3 1Efficacy and Safety Evaluation Department, Benefit and Risk Evaluation Directorate, Saudi Food and Drug Authority (SFDA), Riyadh, Saudi Arabia; 2Drug Sector, Saudi Food and Drug Authority (SFDA), Riyadh, Saudi Arabia; 3Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi ArabiaCorrespondence: Ahmed Fawaz Alkhalidi, Efficacy and Safety Evaluation Department, Benefit and Risk Evaluation Directorate, SFDA, Riyadh, 5163, Saudi Arabia, Tel +966555546169, Email afkhaldi@sfda.gov.saPurpose: In response to the COVID-19 pandemic, the World Health Organization (WHO) developed a set of outcome measures for trials primarily aimed at hospitalised patients. However, a gap exists in defining outcome standards for non-hospitalised patients. Therefore, this study aims to discuss hospitalisation as a primary outcome in outpatient trials and its potential pitfalls, specifically focusing on trials related to anti-SARS-COV-2 therapy.Methods: In this narrative review, researchers thoroughly searched MEDLINE and ClinicalTrials.gov from January 2020 to December 2022, targeting Phase III randomized controlled trials involving outpatients with mild-to-moderate COVID-19. The trials were specifically related to anti-SARS-COV-2 monoclonal antibodies or antiviral agents. The study collected essential data, including the type of intervention, comparator, primary objective, primary endpoint, and the use of estimands in the trial.Results: The search identified 12 trials that evaluated the efficacy of anti-SARS COV-2 therapies in a predefined population. Three studies used hospitalisation and death as primary endpoints in high-risk patients receiving monoclonal antibodies. Nine studies assessed the efficacy of several antiviral agents: four trials used hospitalisation and death as the main endpoints, while others used different measures such as v
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- 2024
5. Blood pressure–lowering activity of statins: a systematic literature review and meta-analysis of placebo-randomized controlled trials
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Alghamdi, Jahad, Alqadi, Abdulziz, Alharf, Adel, Almuzzaini, Bader, Mahmud, Azra, Barhoumi, Tlili, Badreldin, Hisham A, Alaamery, Manal, and Padmanabhan, Sandosh
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- 2020
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6. Prevalence of and clinical characteristics associated with microalbuminuria in hypertension
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Alharf, Adel Abdullah
- Subjects
616.1 ,RM Therapeutics. Pharmacology - Abstract
Cardiovascular disease is the leading cause of mortality. As blood pressure is one of the most important risk factors for cardiovascular disease, effective management of hypertension is critical in reducing this risk. In addition to high blood pressure, however, several factors have been identified as predictors of future cardiovascular events. These include high cholesterol, cigarette smoking, obesity and diabetes. Taken together, these traditional risk factors do not entirely explain the risk. Thus, many novel risk factors have been proposed for risk prediction of cardiovascular disease. Microalbuminuria is one such factor. Microalbuminuria is defined as excretion of albumin in the urine above the normal level but less than gross proteinuria. As excretion of albumin exhibits high variability due to many confounders (such as urinary tract infection and strenuous exercise), diagnosis of microalbuminuria should be ideally based on screening of multiple samples using either 24-hour urine collection or first-morning voids. Much evidence suggests that microalbuminuria is a reflection of generalised endothelial dysfunction. This is supported by the observation that microalbuminuria is strongly associated with cardiovascular disease. My main aim was to study microalbuminuria in people with hypertension attending specialist clinics. Microalbuminuria has been investigated extensively in diabetes and in patients with renal disease. However, the available information on the association of microalbuminuria with hypertension has many limitations since many studies had small sample size, restricted population or were confounded by potential misdiagnosis of microalbuminuria by the use of single samples. This has led to uncertainty about the prevalence of microalbuminuria in hypertension, where reported prevalence ranges from 4.7% to 58%, and probable underestimation of its clinical significance. I addressed these issues by conducting a series of studies in 1059 hypertensive subjects attending the Glasgow Blood Pressure Clinic or the Aberdeen Hypertension Clinic. Each patient was invited to provide an early morning urine specimen for the assessment of albuminuria. Urinary tract infection was tested using urine strips and, where positive, samples were discarded. If the first sample showed increased albumin excretion, two further samples were requested. Albuminuria (microalbuminuria or gross proteinuria) was diagnosed when two out of the three samples showed increased albuminuria. Two definitions of microalbuminuria were used in the analysis, a conventional definition with the threshold used by most therapeutic guidelines and a new definition that accounts for low excretion of albumin. All patient information was obtained from case-records. In the first study, I showed that microalbuminuria by the conventional definition was present in 9.5% of non-diabetic hypertensive subjects without renal impairment. Another 10% of this cohort had microalbuminuria by the new definition. Compared with people with normal urinary albumin, individuals with microalbuminuria by both definitions (n= 786, after excluding those with diabetes or severe renal impairment) had significantly higher blood pressure, higher pulse pressure, increased levels of inflammatory markers, poorer renal function, higher triglycerides levels and used more cardiovascular drugs. In a second study, the association of microalbuminuria with clinical characteristics was investigated. Subjects with microalbuminuria had increased prevalence of risk factors / co-morbidities such as left ventricular hypertrophy (19.2% in normoalbuminuria versus 29.7% and 34.8% for microalbuminuria by the new and the conventional definitions, respectively), ECG abnormalities and cardiovascular disease. In addition, people with microalbuminuria had higher risk scores for subsequent cardiovascular events using two risk calculators, the Framingham and the Joint British Societies equations. In a subcohort with controlled blood pressure and without co-morbidities or risk, microalbuminuria (by combining the two definitions) was found in 14%. Compared with those with normoalbuminuria, subjects with microalbuminuria had higher blood pressure, poorer renal function, higher blood glucose and higher levels of inflammatory markers although the limited sample size precluded statistical significance. In a further study, the independent association of microalbuminuria with different risk factors was evaluated using multivariate testing. Systolic blood pressure, serum creatinine, left ventricular hypertrophy and fasting triglycerides were among factors linked with microalbuminuria. The risk of microalbuminuria increased in people with poorly controlled blood pressure. I also found that microalbuminuria was associated strongly with left ventricular hypertrophy [odds ratio 1.87 (95% CI, 1.12 - 3.12) for a composite of both definitions- the combined definition] and cardiovascular abnormalities [odds ratio 1.72 (95% CI, 1.05 - 2.80) for the combined definition]. In a fourth study, the reproducibility of microalbuminuria screening was investigated. I discovered that a large proportion of people who had increased urinary albumin excretion on first sample was categorised as normoalbuminuria based on the result of multiple samples (48% at the Glasgow Clinic and 41% at the Aberdeen Clinic). This indicates that even after controlling microalbuminuria confounders, multiple testing can be recommended for more accurate diagnosis. In the final study, I demonstrated that subjects with microalbuminuria by both definitions attending the Glasgow Blood Pressure Clinic had relatively high blood pressure and pulse pressure at first visit and subsequently. This finding indicates that subjects with microalbuminuria require particularly rigorous blood pressure management to achieve blood target blood pressure. Furthermore, individuals with microalbuminuria may be at risk for cardiovascular disease greater than that in those with normoalbuminuria since the eventual blood pressure remained higher in these subjects. Together with the observations that microalbuminuria is associated with clustering of cardiovascular risk factors, my finding support the importance of even small increase in urine albumin excretion as an indicator of eventual cardiovascular disease. In conclusion, microalbuminuria is found in one-fifth of subjects with essential hypertension. Although my investigation was observational, the large sample size, the use of multiple samples and allowance for the effects of potential confounders enhances the precision of the results. Moreover, subjects involved in this study represent a real hypertension population with few restrictions. My findings support the value of microalbuminuria as a tool to identify subjects at high risk for cardiovascular disease. Before routine screening can be recommended, these observations require confirmation in clinical trials and prospective studies with long-term follow up. Linkage of the records of the patients who participated in this series of studies with national morbidity and mortality statistics offers one approach with the potential to test the clinical relevance of my findings.
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- 2012
7. Strengthening the Pharmaceutical System in the Kingdom of Saudi Arabia : Towards a Medicine Policy to Support Vision 2030
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Alghaith, Taghred, Almoteiry, Khalid, Alamri, Adwa, Alluhidan, Mohammed, Alharf, Adel, Al-Hammad, Bander, Aliafali, Ibrahim, Seiter, Andreas, Pisani, Elizabeth, Herbst, Christopher H., El-Saharty, Sameh, and Alazemi, Nahar
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PHARMACEUTICAL INDUSTRY ,MEDICINE POLICY ,ACCESS TO HEALTH CARE ,PHARMACEUTICAL SYSTEM ,MEDICINE PRICING - Abstract
This document presents the major issues that were discussed in the process of working towards the development of a new medicines policy in Saudi Arabia, examining current national practice in light of international practices and experiences. The document is designed to foster discussion and help inform the development of a new national medicine policy. A detailed accounting of the evidence informing policy choices to be highlighted in an updated medicine policy are presented in Part I of this discussion paper; a proposed new National Medicine Policy itself is presented in Part ll. A new Medicine policy, once finalized and approved, will need to be implemented in a highly dynamic environment and must therefore allow for flexibility. It will need to be followed by the implementation of regulations, closely monitored, and adapted as necessary over time.
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- 2020
8. Strengthening the Pharmaceutical System in the Kingdom of Saudi Arabia
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Alghaith, Taghred, primary, Almoteiry, Khalid, additional, Alamri, Adwa, additional, Alluhidan, Mohammed, additional, Alharf, Adel, additional, Al-Hammad, Bander, additional, Aliafali, Ibrahim, additional, Seiter, Andreas, additional, Pisani, Elizabeth, additional, Herbst, Christopher H., additional, El-Saharty, Sameh, additional, and Alazemi, Nahar, additional
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- 2020
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9. Saudi Vigilance Program: Challenges and lessons learned
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Alharf, Adel, primary, Alqahtani, Nasser, additional, Saeed, Ghazi, additional, Alshahrani, Ali, additional, Alshahrani, Mubarak, additional, Aljasser, Nasser, additional, Alquwaizani, Mohammed, additional, and Bawazir, Saleh, additional
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- 2018
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10. Top 10 most used drugs in the Kingdom of Saudi Arabia 2010–2015
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AlKhamees, Osama A., primary, AlNemer, Khaled A., additional, Bin Maneea, Mohammed W., additional, AlSugair, Faisal A., additional, AlEnizi, Bassam H., additional, and Alharf, Adel A., additional
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- 2018
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11. Prevalence of and clinical characteristics associated with microalbuminuria in hypertension
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Alharf, Adel Abdullah and Alharf, Adel Abdullah
- Abstract
Cardiovascular disease is the leading cause of mortality. As blood pressure is one of the most important risk factors for cardiovascular disease, effective management of hypertension is critical in reducing this risk. In addition to high blood pressure, however, several factors have been identified as predictors of future cardiovascular events. These include high cholesterol, cigarette smoking, obesity and diabetes. Taken together, these traditional risk factors do not entirely explain the risk. Thus, many novel risk factors have been proposed for risk prediction of cardiovascular disease. Microalbuminuria is one such factor. Microalbuminuria is defined as excretion of albumin in the urine above the normal level but less than gross proteinuria. As excretion of albumin exhibits high variability due to many confounders (such as urinary tract infection and strenuous exercise), diagnosis of microalbuminuria should be ideally based on screening of multiple samples using either 24-hour urine collection or first-morning voids. Much evidence suggests that microalbuminuria is a reflection of generalised endothelial dysfunction. This is supported by the observation that microalbuminuria is strongly associated with cardiovascular disease. My main aim was to study microalbuminuria in people with hypertension attending specialist clinics. Microalbuminuria has been investigated extensively in diabetes and in patients with renal disease. However, the available information on the association of microalbuminuria with hypertension has many limitations since many studies had small sample size, restricted population or were confounded by potential misdiagnosis of microalbuminuria by the use of single samples. This has led to uncertainty about the prevalence of microalbuminuria in hypertension, where reported prevalence ranges from 4.7% to 58%, and probable underestimation of its clinical significance. I addressed these issues by conducting a series of studies in 1059 hypertensive subje
12. Prevalence of and clinical characteristics associated with microalbuminuria in hypertension
- Author
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Alharf, Adel Abdullah and Alharf, Adel Abdullah
- Abstract
Cardiovascular disease is the leading cause of mortality. As blood pressure is one of the most important risk factors for cardiovascular disease, effective management of hypertension is critical in reducing this risk. In addition to high blood pressure, however, several factors have been identified as predictors of future cardiovascular events. These include high cholesterol, cigarette smoking, obesity and diabetes. Taken together, these traditional risk factors do not entirely explain the risk. Thus, many novel risk factors have been proposed for risk prediction of cardiovascular disease. Microalbuminuria is one such factor. Microalbuminuria is defined as excretion of albumin in the urine above the normal level but less than gross proteinuria. As excretion of albumin exhibits high variability due to many confounders (such as urinary tract infection and strenuous exercise), diagnosis of microalbuminuria should be ideally based on screening of multiple samples using either 24-hour urine collection or first-morning voids. Much evidence suggests that microalbuminuria is a reflection of generalised endothelial dysfunction. This is supported by the observation that microalbuminuria is strongly associated with cardiovascular disease. My main aim was to study microalbuminuria in people with hypertension attending specialist clinics. Microalbuminuria has been investigated extensively in diabetes and in patients with renal disease. However, the available information on the association of microalbuminuria with hypertension has many limitations since many studies had small sample size, restricted population or were confounded by potential misdiagnosis of microalbuminuria by the use of single samples. This has led to uncertainty about the prevalence of microalbuminuria in hypertension, where reported prevalence ranges from 4.7% to 58%, and probable underestimation of its clinical significance. I addressed these issues by conducting a series of studies in 1059 hypertensive subje
13. Prevalence of and clinical characteristics associated with microalbuminuria in hypertension
- Author
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Alharf, Adel Abdullah and Alharf, Adel Abdullah
- Abstract
Cardiovascular disease is the leading cause of mortality. As blood pressure is one of the most important risk factors for cardiovascular disease, effective management of hypertension is critical in reducing this risk. In addition to high blood pressure, however, several factors have been identified as predictors of future cardiovascular events. These include high cholesterol, cigarette smoking, obesity and diabetes. Taken together, these traditional risk factors do not entirely explain the risk. Thus, many novel risk factors have been proposed for risk prediction of cardiovascular disease. Microalbuminuria is one such factor. Microalbuminuria is defined as excretion of albumin in the urine above the normal level but less than gross proteinuria. As excretion of albumin exhibits high variability due to many confounders (such as urinary tract infection and strenuous exercise), diagnosis of microalbuminuria should be ideally based on screening of multiple samples using either 24-hour urine collection or first-morning voids. Much evidence suggests that microalbuminuria is a reflection of generalised endothelial dysfunction. This is supported by the observation that microalbuminuria is strongly associated with cardiovascular disease. My main aim was to study microalbuminuria in people with hypertension attending specialist clinics. Microalbuminuria has been investigated extensively in diabetes and in patients with renal disease. However, the available information on the association of microalbuminuria with hypertension has many limitations since many studies had small sample size, restricted population or were confounded by potential misdiagnosis of microalbuminuria by the use of single samples. This has led to uncertainty about the prevalence of microalbuminuria in hypertension, where reported prevalence ranges from 4.7% to 58%, and probable underestimation of its clinical significance. I addressed these issues by conducting a series of studies in 1059 hypertensive subje
14. Prevalence of and clinical characteristics associated with microalbuminuria in hypertension
- Author
-
Alharf, Adel Abdullah and Alharf, Adel Abdullah
- Abstract
Cardiovascular disease is the leading cause of mortality. As blood pressure is one of the most important risk factors for cardiovascular disease, effective management of hypertension is critical in reducing this risk. In addition to high blood pressure, however, several factors have been identified as predictors of future cardiovascular events. These include high cholesterol, cigarette smoking, obesity and diabetes. Taken together, these traditional risk factors do not entirely explain the risk. Thus, many novel risk factors have been proposed for risk prediction of cardiovascular disease. Microalbuminuria is one such factor. Microalbuminuria is defined as excretion of albumin in the urine above the normal level but less than gross proteinuria. As excretion of albumin exhibits high variability due to many confounders (such as urinary tract infection and strenuous exercise), diagnosis of microalbuminuria should be ideally based on screening of multiple samples using either 24-hour urine collection or first-morning voids. Much evidence suggests that microalbuminuria is a reflection of generalised endothelial dysfunction. This is supported by the observation that microalbuminuria is strongly associated with cardiovascular disease. My main aim was to study microalbuminuria in people with hypertension attending specialist clinics. Microalbuminuria has been investigated extensively in diabetes and in patients with renal disease. However, the available information on the association of microalbuminuria with hypertension has many limitations since many studies had small sample size, restricted population or were confounded by potential misdiagnosis of microalbuminuria by the use of single samples. This has led to uncertainty about the prevalence of microalbuminuria in hypertension, where reported prevalence ranges from 4.7% to 58%, and probable underestimation of its clinical significance. I addressed these issues by conducting a series of studies in 1059 hypertensive subje
15. The bioequivalence study design recommendations for immediate-release solid oral dosage forms in the international pharmaceutical regulators programme participating regulators and organisations: differences and commonalities.
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Fernandes EAF, van Oudtshoorn J, Tam A, González LCA, Aurela EG, Potthast H, Mettke K, Kuribayashi R, Shimojo K, Kasuga M, Morales L, Rodríguez Z, Jones B, Ahn C, Yun E, Kim SH, Rodrigues C, Tiong T, Crane C, Walther C, Roost MS, Chen TL, Hsu LF, Braddy AC, García-Arieta A, Abalos I, Divinsky M, Alsuwyeh A, Alzenaidy B, and Alharf A
- Subjects
- Humans, Therapeutic Equivalency, Drugs, Generic, Research Design
- Abstract
Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product. The objective of this article is to describe the recommendations from participating Bioequivalence Working Group for Generics (BEWGG) members of the International Pharmaceutical Regulators Programme (IPRP) regarding the conduct and acceptance criteria for BE studies of immediate release solid oral dosage forms. A survey was conducted among BEWGG members regarding their BE recommendations and requirements related to study subjects, study design, sample size, single or multiple dose administration, study conditions (fasting or fed), analyte to be measured, selection of product strength, drug content, handling of endogenous substances, BE acceptance criteria, and additional design aspects. All members prefer conducting single dose cross-over designed studies in healthy subjects with a minimum of 12 subjects and utilizing the parent drug data to assess BE. However, differences emerged among the members when the drug's pharmacokinetics and pharmacodynamics become more complex, such that the study design (e.g., fasting versus fed conditions) and BE acceptance criteria (e.g., highly variable drugs, narrow therapeutic index drugs) may be affected. The survey results and discussions were shared with the ICH M13 Expert Working Group (EWG) and played an important role in identifying and analyzing gaps during the harmonization process. The draft ICH M13A guideline developed by the M13 EWG was endorsed by ICH on 20 December 2022, under Step 2 ., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Fernandes, Oudtshoorn, Tam, González, Aurela, Potthast, Mettke, Kuribayashi, Shimojo, Kasuga, Morales, Rodríguez, Jones, Ahn, Yun, Kim, Rodrigues, Tiong, Crane, Walther, Roost, Chen, Hsu, Braddy, García-Arieta, Abalos, Divinsky, Alsuwyeh, Alzenaidy and Alharf.)
- Published
- 2024
- Full Text
- View/download PDF
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