Results 41 to 50 of about 32,756 (214)

A pharmacokinetic comparison of three pharmaceutical formulations of nimesulide in healthy volunteers [PDF]

, 2005
Background/Aim. Switching the patient from one pharmaceutical formulation of the same drug to another, may lead to therapeutic inadequancy in some cases. To minimize the risk, careful pharmacokinetic studies are desired in the pre-registration period and
Jovanović Dušan, Kilibarda Vesna, Potrebić Olivera, Todorović Veljko   +3 more
core   +1 more source

Advancing pharmacometrics in Africa—Transition from capacity development toward job creation

CPT: Pharmacometrics &Systems Pharmacology, Volume 14, Issue 3, Page 407-419, March 2025.
Abstract Trained pharmacometricians remain scarce in Africa due to limited training opportunities, lack of a pharmaceutical product development ecosystem, and emigration to high‐income countries. The Applied Pharmacometrics Training (APT) fellowship program was established to address these gaps and specifically foster job creation for talent retention.
Goonaseelan (Colin) Pillai, Samer Mouksassi, Innocent G. Asiimwe, Craig R. Rayner, Steven Kern, Phumla Sinxadi, Paolo Denti, Eric Decloedt, Catriona Waitt, Bernhards R. Ogutu, Rik de Greef   +10 more
wiley   +1 more source

Semiparametric Bayesian Modeling of Multivariate Average Bioequivalence [PDF]

, 2006
Bioequivalence trials are usually conducted to compare two or more formulations of a drug. Simultaneous assessment of bioequivalence on multiple endpoints is called multivariate bioequivalence.
Ghosh, Pulak, Dr., Gonen, Mithat
core   +1 more source

Harnessing Natural Compounds in Psoriasis: Targeting Cellular Pathways for Effective Therapy

Phytotherapy Research, EarlyView.
Natural compounds act on key cellular pathways in psoriasis by suppressing keratinocyte hyperproliferation, modulating Th17/IL‐17‐mediated immune responses, and reducing oxidative stress. These multi‐target effects highlight their potential as safer adjunctive therapies alongside conventional treatments.
Hye Jin Lee, Yu Jin So, Il‐Joo Jo, Ji Yong Jang, Tae Han Yook, Jun Ho Lee, Sung Wook Kim, Kangwook Lee, Soo Jung Park, Gabsik Yang   +9 more
wiley   +1 more source

Coherent frequentism [PDF]

, 2009
By representing the range of fair betting odds according to a pair of confidence set estimators, dual probability measures on parameter space called frequentist posteriors secure the coherence of subjective inference without any prior distribution.
Datta G. S., David R. Bickel, Fisher R. A., Fisher R. A., Gleser L. J., Hacking I., Hannig J., Kaplan M., Kyburg H. E. J., Molchanov I., Paris J. B., Pawitan Y., Smith C. A. B., Walley P., Welch B. L., Wilkinson G. N., Williamson J.   +16 more
core   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

Pediatric Investigation Plans for seizure and epilepsy treatments: An analysis since the implementation of the European Pediatric Regulation in 2006

Epilepsia, EarlyView.
Abstract Objective A Pediatric Investigation Plan (PIP) implemented under the European Pediatric Regulation (EC No. 1901/2006) aims to ensure early and systematic evaluation of medicines for children. We analyze PIPs for antiseizure medications (ASMs) submitted to the European Medicines Agency (EMA) since 2006, characterizing their content, focusing on
Valeria Agostini, Stéphane Auvin
wiley   +1 more source

Evaluating Model‐Based Extrapolation of Plasma Exposure for Long‐Acting Injectable Products: From Single‐ to Multiple‐Dose Trials

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 2, February 2026.
ABSTRACT Long‐acting injectable medicinal products (LAIs) prolong drug release and thereby aim to enhance adherence and patient outcomes. European regulatory guidelines require the conduct of single‐ and multiple‐dose trials to exclude differences in drug release between non‐steady and steady state conditions. The complexity of these trials may however
D. Esther Lubberts, Douglas J. Eleveld, Laurens F. M. Verscheijden, Pieter J. Colin, Jeroen V. Koomen   +4 more
wiley   +1 more source

Bioequivalence study of two brands of phenytoin sodium 100mg formulations in healthy adult male rabbits [PDF]

, 2013
The objective of the study was to compare the bioavailability of a single oral 100 mg dose of two brands of phenytoin sodium formulations available in the Nepalese market.
Banskota, Suhrid, Basnet, Shova, Gupta, Biki, Lohani, Shyam Prasad, Marasini, Nirmal, Nepal, Saroj, Regmi, Bal Mukunda   +6 more
core   +1 more source

Validating Physiologically‐Based Pharmacokinetic Models Using the Continuous Ranked Probability Score: Beyond Being Correct on Average

CPT: Pharmacometrics &Systems Pharmacology, Volume 15, Issue 2, February 2026.
ABSTRACT Physiologically‐based pharmacokinetic (PBPK) models have become increasingly popular for model‐informed drug development (MIDD) over the past decade. While several guidelines for model evaluation exist, these are by design often of a general and non‐specific nature. It is clear what steps should be carried out but not necessarily how.
Laurens Sluijterman, Marjolein van Borselen, Rick Greupink, Joanna IntHout   +3 more
wiley   +1 more source