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1. A quality control system for ligand-binding assay of plasma renin activity: Proof-of-concept within a pharmacodynamic study

Author

Läer, Stephanie, Breitkreutz, Jörg, Klingmann, Ingrid, Lagler, Florian, de Hoon, Jan, Dalinghaus, Michiel, Bajcetic, Milica, de Wildt, Saskia, Clarke, Anne Keatley, Breur, Johannes, Male, Christoph, Ablonczy, Laslo, Mir, Thomas, Vukomanovic, Vladislav, Dukic, Milan, Jovanovic, Ida, Burckhardt, Bjoern B., Cawello, Willi, Kleine, Karl, Moder, Angelika, Obarcanin, Emina, Wagner, Peter, Walsh, Jennifer, van Hecken, Anne, Spatenkova, Lucie, Ali, Mohsin, Božić, Bojana, Burdman, Maja Bijelić Ilja, Ciplea, Agnes, Faisal, Muhammad, Farahani, Samieh, Feickert, Martin, Gangnus, Tanja, Lazic, Milica, Makowski, Nina, Suessenbach, Fabian, van der Meulen, Marijke, Popović, Saša, Parezanović, Miro, Smeets, Nori, Swoboda, Vanessa, Bojanin, Dragana, Đorđević, Stefan, Dragić, Jasminka, Holle, Ann-Kathrin, Jovičić, Bosiljka, Košutić, Jovan, Kozomara, Gordana, Majid, Haidara, Mitrović, Jadranka, Ninić, Sanja, Parezanovic, Miro, Parezanovic, Vojislav, Pavlović, Andrija, Prijić, Sergej, Rebić, Branislava, Stefanović, Igor, Tordas, Daniel, Vulićević, Irena, Bartels, Anke, Čeko, Andjelka, Herborts, Marissa, Hennink, Annelies, Kosanović, Bosiljka, Kostic, Sanja, Isailović, Ljiljana, Maksimovic, Jasmina, Manai, Badies, Martinović, Nada, Máté, Gyöngyi, Perišić, Miloš, Reljić, Jelena, Salamomovic, Regina Pirker Marta, Schlesner, Claudia, Tins, Jutta, Wissmann, Eva, Suessenbach, Fabian Konstantin, and Burckhardt, Bjoern Bengt

Published
2020
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6. Palmar and Finger Ridge Count in Two Isolated Slavic Muslim Populations (Zhupa and Gora) from Kosovo in Comparison with Kosovo Albanians

Author

Zajc Petranović, Matea, Tomas, Željka, Škarić-Jurić, Tatjana, Moder, Angelika, Xharra, Shefki, Sopi, Kumrije, Hadžiselimović, Rifat, Nefić, Hilada, and Temaj, Gazmend

Subjects
quantitative dermatoglyphic traits, Slavic Muslim populations, Zhupa region, Gora region, Kosovo
Abstract

In order to compare two geographically and culturally isolated ethnic groups of Slavic Muslims from Zhupa and Gora regions in Kosovo, we analyzed their quantitative dermatoglyphic traits, compared them with each other and with the majority, Albanian population. The dermatoglyphs were collected from a total of 263 Zhuplyani, 145 Gorani, and 213 Albanians of both sexes. The ANOVA analysis showed more differences between the Albanians and both minority populations, than between Zhupa and Gora regions populations themselves. We also detected selective inertia in Slavic Muslim women. The canonical discriminant analysis grouped the Gora and the Zhupa women together, and at the same time closer to the Gora men than to the Kosovo Plain women. The Gora and Zhupa men were much closer to each other than to the men from Kosovo Plain. To conclude, the Gora and Zhupa populations differ less from each other, than any of them differs from Kosovo Albanians.

Published
2020

9. A quality control system for ligand-binding assay of plasma renin activity: Proof-of-concept within a pharmacodynamic study

Author

Suessenbach, Fabian Konstantin, primary, Makowski, Nina, additional, Feickert, Martin, additional, Gangnus, Tanja, additional, Tins, Jutta, additional, Burckhardt, Bjoern Bengt, additional, Läer, Stephanie, additional, Breitkreutz, Jörg, additional, Klingmann, Ingrid, additional, Lagler, Florian, additional, de Hoon, Jan, additional, Dalinghaus, Michiel, additional, Bajcetic, Milica, additional, de Wildt, Saskia, additional, Clarke, Anne Keatley, additional, Breur, Johannes, additional, Male, Christoph, additional, Ablonczy, Laslo, additional, Mir, Thomas, additional, Vukomanovic, Vladislav, additional, Dukic, Milan, additional, Jovanovic, Ida, additional, Burckhardt, Bjoern B., additional, Cawello, Willi, additional, Kleine, Karl, additional, Moder, Angelika, additional, Obarcanin, Emina, additional, Wagner, Peter, additional, Walsh, Jennifer, additional, van Hecken, Anne, additional, Spatenkova, Lucie, additional, Ali, Mohsin, additional, Božić, Bojana, additional, Burdman, Maja Bijelić Ilja, additional, Ciplea, Agnes, additional, Faisal, Muhammad, additional, Farahani, Samieh, additional, Lazic, Milica, additional, Suessenbach, Fabian, additional, van der Meulen, Marijke, additional, Popović, Saša, additional, Parezanović, Miro, additional, Smeets, Nori, additional, Swoboda, Vanessa, additional, Bojanin, Dragana, additional, Đorđević, Stefan, additional, Dragić, Jasminka, additional, Holle, Ann-Kathrin, additional, Jovičić, Bosiljka, additional, Košutić, Jovan, additional, Kozomara, Gordana, additional, Majid, Haidara, additional, Mitrović, Jadranka, additional, Ninić, Sanja, additional, Parezanovic, Miro, additional, Parezanovic, Vojislav, additional, Pavlović, Andrija, additional, Prijić, Sergej, additional, Rebić, Branislava, additional, Stefanović, Igor, additional, Tordas, Daniel, additional, Vulićević, Irena, additional, Bartels, Anke, additional, Čeko, Andjelka, additional, Herborts, Marissa, additional, Hennink, Annelies, additional, Kosanović, Bosiljka, additional, Kostic, Sanja, additional, Isailović, Ljiljana, additional, Maksimovic, Jasmina, additional, Manai, Badies, additional, Martinović, Nada, additional, Máté, Gyöngyi, additional, Perišić, Miloš, additional, Reljić, Jelena, additional, Salamomovic, Regina Pirker Marta, additional, Schlesner, Claudia, additional, and Wissmann, Eva, additional

Published
2020
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10. A comprehensive quality control system suitable for academic research: application in a pediatric study

Author

Makowski, Nina, primary, Ciplea, Agnes M, additional, Ali, Mohsin, additional, Burdman, Ilja, additional, Bartel, Anke, additional, Burckhardt, Bjoern B, additional, Läer, Stephanie, additional, Breitkreutz, Jörg, additional, Klingmann, Ingrid, additional, Lagler, Florian, additional, de Hoon, Jan, additional, Dalinghaus, Michel, additional, Bajcetic, Milica, additional, de Wildt, Saskia, additional, Keatley Clarke, Anne, additional, Breur, Johannes, additional, Male, Christoph, additional, Ablonczy, Laslo, additional, Mir, Thomas, additional, Vukomanovic, Vladislav, additional, Dukic, Milan, additional, Jovanovic, Ida, additional, Burckhardt, Bjoern, additional, Cawello, Willi, additional, Kleine, Karl, additional, Moder, Angelika, additional, Obarcanin, Emina, additional, Wagner, Peter, additional, Walsh, Jennifer, additional, van Hecken, Anne, additional, Spatenkova, Lucie, additional, Mohsin, Ali, additional, Božić, Bojana, additional, Bijelić, Maja, additional, Ciplea, Agnes, additional, Faisal, Muhammed, additional, Farahani, Samieh, additional, Feickert, Martin, additional, Gangnus, Tanja, additional, Lazic, Milica, additional, Makowski, Nina, additional, Süssenbach, Fabian, additional, van der Meulen, Marijke, additional, Popović, Saša, additional, Parezanović, Miro, additional, Smeets, Nori, additional, Swoboda, Vanessa, additional, Bojanin, Dragana, additional, Đorđević, Stefan, additional, Dragić, Jasminka, additional, Holle, Ann-Kathrin, additional, Jovičić, Bosiljka, additional, Košutić, Jovan, additional, Kozomara, Gordana, additional, Majid, Haidara, additional, Mitrović, Jadranka, additional, Ninić, Sanja, additional, Parezanovic, Miro, additional, Parezanovic, Vojislav, additional, Pavlović, Andrija, additional, Prijić, Sergej, additional, Rebić, Branislava, additional, Stefanović, Igor, additional, Tordas, Daniel, additional, Vulićević, Irena, additional, čeko, Andjelka, additional, Herborts, Marissa, additional, Hennink, Annelies, additional, Kosanović, Bosiljka, additional, Kostic, Sanja, additional, Isailović, Ljiljana, additional, Maksimovic, Jasmina, additional, Manai, Badies, additional, Martinović, Nada, additional, Máté, Gyöngyi, additional, Perišić, Miloš, additional, Reljić, Jelena, additional, Pirker, Regina, additional, Salamomovic, Marta, additional, Schlesner, Claudia, additional, Tins, Jutta, additional, and Wissmann, Eva, additional

Published
2020
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11. Three Patterns of Inheritance of Quantitative Dermatoglyphic Traits: Kosovo Albanian Twin Study.

Author

Temaj, Gazmend, Škarić-Jurić, Tatjana, Butković, Ana, Behluli, Emir, Zajc Petranović, Matea, and Moder, Angelika

Subjects
QUANTITATIVE genetics, TWIN studies, GENETIC models, TWINS, FETAL development, GOODNESS-of-fit tests
Abstract

Dermatoglyphs are epidermal ridge configurations on the fingers, palms and soles that are formed during fetal development, and therefore only the intrauterine environment can have any influence on their formation. This study aims at investigating the genetic and environmental contribution in determining quantitative dermatoglyphic traits in 32 monozygotic (MZ) and 35 dizygotic (DZ) same-sex twins from the Albanian population of Kosovo. All genetic analyses were run in the statistical program Mx. After assumptions testing, based on the pattern of MZ-DZ correlations, univariate models were fitted to the data in order to estimate additive genetic (A), common (C) and individual (E) environmental influences for all variables. The exception was the atd-angle for which a model with nonadditive genetic (D) influences was tested, since DZ correlations were less than half of MZ correlations. Goodness of fit of the full ACE or ADE model was compared to the saturated model. The fit of nested models (AE, CE, DE or E) was compared to the full models (ACE or ADE). Our results indicate that additive genetic component strongly contributes to individual differences in finger ridge counts (49-81%), and weakly (0-50%) on the formation of the palmar ridge counts between the palmar triradii a, b, c, and d. The specific pattern found for the atd-angle implies the impact of a nonadditive genetic component, possibly the effect of a major gene. Further, more powered studies are needed to confirm this pattern, especially for resolving the issue of the huge difference in MZ and DZ twin similarity for the atd-angle palmar trait. [ABSTRACT FROM AUTHOR]

Published
2021
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12. Simultaneous Semi-Mechanistic Population Pharmacokinetic Modeling Analysis of Enalapril and Enalaprilat Serum and Urine Concentrations From Child Appropriate Orodispersible Minitablets

Author

Faisal, Muhammad, Cawello, Willi, Burckhardt, Bjoern B, de Hoon, Jan, Laer, Stephanie, van Hecken, Anne, Herbort, Marissa, Breitkreutz, Joerg, Wiedey, Wolfgang, Klingmann, Ingrid, Spatenkova, Lucie, Lagler, Florian, Moder, Angelika, and Khalil, Feras

Subjects
Enalaprilat, enalaprilat, Population, heart failure, TRANSIT, 030204 cardiovascular system & hematology, Pharmacology, 030226 pharmacology & pharmacy, Pediatrics, enalapril, child appropriate dosage forms, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, medicine, ABSORPTION, Enalapril, orodispersible mini-tablets, DRUG, education, FORMULATION, Active metabolite, NONMEM, Original Research, Volume of distribution, education.field_of_study, DISPOSITION, Science & Technology, population pharmacokinetics modeling analysis, business.industry, lcsh:RJ1-570, lcsh:Pediatrics, 3. Good health, ETIOLOGY, CONVERTING ENZYME-INHIBITORS, Pharmacodynamics, Pediatrics, Perinatology and Child Health, HEART-FAILURE, business, Life Sciences & Biomedicine, medicine.drug
Abstract

Enalapril is recommended as the first line of therapy and is proven to improve survival rates for treatment of Pediatric Heart Failure; however, an approved drug and child appropriate dosage formulation is still absent. The present analysis was conducted to perform a detailed model informed population pharmacokinetic analysis of prodrug enalapril and its active metabolite enalaprilat in serum and urine. Further, a model informed dosage form population-pharmacokinetic analysis was conducted to evaluate differences in pharmacokinetics of enalapril and its active metabolite enalaprilat when prodrug was administered to 24 healthy adults in a crossover, two periods, two treatments, phase I clinical trial using child-appropriate orodispersible mini-tablets (ODMT) and reference (Renitec®) dosage formulation. A simultaneous semi-mechanistic population-pharmacokinetic model was developed using NONMEM software, which predicted full profile serum and urine concentrations of enalapril and enalaprilat. First-order conditional estimation with interaction was used for parameter estimation. Transit compartments added using Erlang distribution method to predicted enalapril absorption and enalaprilat formation phases. Normalized body weight was identified as covariate related to enalapril volume of distribution. Visual predictive check (VPC) plots and conducted bootstrap analysis validated the model. The data from the two formulations were pooled for population-pharmacokinetic analysis and covariate effect of the formulation was found on mean transit time (MTT1) of enalapril absorption. In addition, data of each formulation were modeled separately and the estimated parameters of each individual administered both formulations were correlated using paired samples Wilcoxon rank test (p < 0.05 = significant) which also showed only a significant difference (p = 0.03) in MTT1 i.e., 5 min early appearance of enalapril from ODMT compared to reference tablets. No difference in the pharmacokinetics of active enalaprilat was found from the ODMT compared to the reference formulation. The population pharmacokinetic analysis provided detailed information about the pharmacokinetics of enalapril and enalaprilat, which showed that the ODMT formulation might have similar pharmacodynamic response compared to the reference formulation. ispartof: FRONTIERS IN PEDIATRICS vol:7 ispartof: location:Switzerland status: published

Published
2019

13. Model-dependent pharmacokinetic analysis of enalapril administered to healthy adult volunteers using orodispersible minitablets for use in pediatrics

Author

Faisal, Muhammad, Cawello, Willi, Burckhardt, Bjoern B, Laer, Stephanie, de Hoon, Jan, van Hecken, Anne, Herbort, Marissa, Breitkreutz, Joerg, Wiedey, Wolfgang, Klingmann, Ingrid, Spatenkova, Lucie, Lagler, Florian, Moder, Angelika, and Khalil, Feras

Subjects
0301 basic medicine, Administration, Oral, Pharmaceutical Science, Phases of clinical research, Chemistry, Medicinal, Pharmacology, Models, Biological, enalapril, least square minimization method, orodispersible minitablets, 03 medical and health sciences, 0302 clinical medicine, Enalapril, Pharmacokinetics, Statistical significance, Drug Discovery, medicine, ABSORPTION, Humans, Pharmacology & Pharmacy, Least-Squares Analysis, Child, FORMULATION, Original Research, Mathematics, Volume of distribution, Drug Design, Development and Therapy, Science & Technology, Clinical Trials, Phase I as Topic, REGRESSION-ANALYSIS, PK Parameters, Healthy Volunteers, child-appropriate dosage forms, 3. Good health, Bioavailability, Pharmacokinetic analysis, 030104 developmental biology, 030220 oncology & carcinogenesis, model-dependent pharmacokinetics, HEART-FAILURE, Life Sciences & Biomedicine, Tablets, medicine.drug
Abstract

Muhammad Faisal,* Willi Cawello,* Bjoern B Burckhardt, Stephanie Laer On behalf of LENA Consortium Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany *These authors contributed equally to this work Introduction: Comparative pharmacokinetic (PK) data analysis of drugs administered using developed child-appropriate and market authorized dosage formulation is sparse and is important in pediatric drug development. Objectives: To compare and evaluate any differences in PK of enalapril administered using two treatments of child-appropriate orodispersible minitablets (ODMTs) and market authorized reference tablet formulation (Renitec®) using PK compartment model and validated least square minimization method (LSMM) of parameter estimation. Methods: Full profile data sets were obtained from a phase I clinical trial, whereby three treatments of enalapril, ie, reference tablets with 240 mL water (treatment A), child-appropriate ODMTs with 240 mL (treatment B), and ODMTs dispersed in the mouth with 20 mL water (treatment C), were administered to 24 healthy adult volunteers. Virtual validation analysis was conducted using R program to select accurate and precise LSMM of parameter estimation. For the selection of PK model and estimation of parameters, enalapril data were fitted with one- and two-compartment models with first order of absorption and elimination, with and without incorporated lag time parameter (tlag). The log-transformed PK parameters were statistically compared by the two-sided paired t-test with the level of significance of P

Published
2019

14. Extent, impact, and predictors of diagnostic delay in Pompe disease: A combined survey approach to unveil the diagnostic odyssey

Author

Lagler, Florian B; https://orcid.org/0000-0002-1439-6961, Moder, Angelika, Rohrbach, Marianne, Hennermann, Julia, Mengel, Eugen, Gökce, Seyfullah, Hundsberger, Thomas, Rösler, Kai M, Karabul, Nesrin, Huemer, Martina, Lagler, Florian B; https://orcid.org/0000-0002-1439-6961, Moder, Angelika, Rohrbach, Marianne, Hennermann, Julia, Mengel, Eugen, Gökce, Seyfullah, Hundsberger, Thomas, Rösler, Kai M, Karabul, Nesrin, and Huemer, Martina

Abstract

Background Early diagnosis is of substantial benefit for patients with Pompe disease. Yet underdiagnosing and substantial diagnostic delay are still frequent and the determinants of this are unknown. This study is the first to systematically investigate the diagnostic odyssey in Pompe disease from patients', parents', and physicians' perspectives. Methods Patients with infantile or late onset Pompe disease, their parents as well as their metabolic experts were invited to fill in respective surveys. The survey addressed perceived disease symptoms at onset and during the course of the disease, specialties of involved physicians, activities of patient-initiated search for diagnosis and the perceived impact of time to diagnosis on outcome. Results of experts' and patients'/parents' surveys were compared and expressed by descriptive statistics. Results and Discussion We collected data on 15 males and 17 females including 9 infantile and 23 late onset Pompe patients. All received the correct diagnosis at a metabolic or musculoskeletal expert center. Patients with direct referral to the expert center had the lowest diagnostic delay, while patients who were seen by several physicians, received the correct diagnosis after 44%-200% longer delay. The proportion of direct referral varied strongly between pediatricians (57%) and other disciplines (18%-36%). Conclusion Our study highlights a substantially larger diagnostic delay in Pompe patients that are not directly referred to expert centers for diagnostic work. Our findings may be used to develop more successful strategies for early diagnosis. Synopsis Diagnostic delay in Pompe disease is substantial particularly in patients that are not directly referred to expert centers for diagnostic workup, so facilitating direct referral may be a new strategy for early diagnosis.

Published
2019

21. Topical diacerein for epidermolysis bullosa: a randomized controlled pilot study

Author

Wally, Verena, primary, Kitzmueller, Sophie, additional, Lagler, Florian, additional, Moder, Angelika, additional, Hitzl, Wolfgang, additional, Wolkersdorfer, Martin, additional, Hofbauer, Peter, additional, Felder, Thomas K, additional, Dornauer, Michael, additional, Diem, Anja, additional, Eiler, Nora, additional, and Bauer, Johann W, additional

Published
2013
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22. Effects of Ionized Waterfall Aerosol on Pediatric Allergic Asthma

Author

Gaisberger, Martin, primary, Šanović, Renata, additional, Dobias, Heidemarie, additional, Kolarž, Predrag, additional, Moder, Angelika, additional, Thalhamer, Josef, additional, Selimović, Amina, additional, Huttegger, Isidor, additional, Ritter, Markus, additional, and Hartl, Arnulf, additional

Published
2012
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26. Differential expression of GHRH receptor and its splice variant 1 in human normal and malignant mucosa of the oesophagus and colon

Author

Hohla, Florian, primary, Moder, Angelika, additional, Mayrhauser, Ursula, additional, Hauser-Kronberger, Cornelia, additional, Schally, Andrew, additional, Varga, Jozsef, additional, Zarandi, Marta, additional, Buchholz, Stefan, additional, Huber, Rudolf, additional, Aigner, Elmar, additional, Ritter, Markus, additional, and Datz, Christian, additional

Published
2008
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27. Inhibition of estrogen receptor positive and negative breast cancer cell lines with a growth hormone-releasing hormone antagonist.

Author

Seitz S, Hohla F, Schally AV, Moder A, Engel JB, Horn F, Varga J, Zarandi M, Ortmann O, Köster F, and Buchholz S

Subjects
Cell Line, Tumor, Cell Proliferation drug effects, Cell Survival drug effects, Female, Growth Hormone-Releasing Hormone biosynthesis, Growth Hormone-Releasing Hormone drug effects, Humans, RNA, Messenger analysis, Reverse Transcriptase Polymerase Chain Reaction, Sermorelin pharmacology, Antineoplastic Agents pharmacology, Breast Neoplasms metabolism, Growth Hormone-Releasing Hormone antagonists & inhibitors, Receptors, Estrogen metabolism, Sermorelin analogs & derivatives
Abstract

GHRH antagonists have been shown to inhibit growth of various human cancer cell lines xenografted into nude mice including estrogen receptor negative human breast cancers. Previous observations also suggest that GHRH locally produced in diverse neoplasms including breast cancer might directly affect proliferation of tumor cells. In the present study we demonstrate that a novel highly potent GHRH antagonist JMR-132 strongly inhibits the proliferation of both estrogen receptor negative SKBR 3 and estrogen receptor positive ZR 75 human breast cancer cell lines in vitro. The proliferation in vitro of ZR 75 and SKBR 3 was increased after direct stimulation with GHRH(1-29)NH2. The GHRH antagonist JMR-132 had a significant antiproliferative activity in the absence of GHRH and nullified the proliferative effect of GHRH in these cell lines. SKBR 3 and ZR 75 expressed the GHRH ligand as well as the pituitary type of GHRH-receptor, which likely appears to mediate the antiproliferative mechanisms in these cell lines. These in vitro results suggest that JMR-132 is a potent inhibitor of breast cancer growth, independent of the estrogen receptor status. Further investigations on the combination treatment with endocrine agents affecting the estrogen pathway and GRHR antagonists are needed in order to improve the treatment of breast cancer.

Published
2008

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