Results 81 to 90 of about 1,942 (154)

Osimertinib Cost Minimization in Non‐Small Cell Lung Cancer (NSCLC) Treatment: Hypothesis Generation for a Population Pharmacokinetic Approach for Equivalent Dose Optimization of Osimertinib in Combination with Cobicistat

The Journal of Clinical Pharmacology, Volume 65, Issue 12, Page 1687-1698, December 2025.
Abstract Pharmacokinetic boosting can be a strategy to enhance osimertinib exposure and reduce treatment associated costs. The OSIBOOST trial demonstrated that it was feasible to boost low osimertinib plasma trough levels with cobicistat. The current study aims to establish the equivalent dose of cobicistat boosted osimertinib compared to osimertinib ...
Niels Westra, Paul D. Kruithof, Sander Croes, Robin M. J. M. van Geel, Lizza E. L. Hendriks, Daan J. Touw, Jos G. W. Kosterink, Jasper Stevens, Thijs H. Oude Munnink, Paola Mian   +9 more
wiley   +1 more source

University Patent Licensing for the Research and Development of Pharmaceuticals in Developing Countries [PDF]

, 2009
Waiting for permission from publisher - University Patent Licensing for the Research and Development of Pharmaceuticals in Developing Countries” I.P.Q. No.3 [2009] 311-344.University Patent Licensing for the Research and Development of Pharmaceuticals in
Evans, GE
core  

Bioequivalence Studies of Highly Variable Drugs: An Old Problem Addressed by Artificial Neural Networks

Applied Sciences
The bioequivalence (BE) of highly variable drugs is a complex issue in the pharmaceutical industry. The impact of this variability can significantly affect the required sample size and statistical power.
Dimitris Papadopoulos, Georgia Karali, Vangelis D. Karalis   +2 more
doaj   +1 more source

Application of the relationship between pharmacokinetics and pharmacodynamics in drug development and therapeutic equivalence::a PEARRL review [PDF]

, 2019
Objectives: The objective of this review is to provide an overview of PK/PD models, focusing on drug-specific PK/PD models and highlighting their value-added in drug development and regulatory decision-making.
Cristofoletti, Rodrigo, Dressman, Jennifer, Fotaki, Nikoletta, Loisios-Konstantinidis, Ioannis, McAllister, Mark, Paraiso, Rafael L.M.   +5 more
core   +1 more source

PRT to predict pharmacokinetic profiles as part of a bioequivalence study of the drug deferasirox

Разработка и регистрация лекарственных средств
Introduction. Deferasirox is a complexing drug and belongs to class II according to the biopharmaceutical classification system (BCS), has acidic properties and belongs to subclass “a” (acid).
A. V. Suvorova, P. A. Losenkova, Yu. V. Medvedev, E. A. Malashenko, I. E. Makarenko, A. M. Poluyanov, I. E. Shohin   +6 more
doaj   +1 more source

Examination of effectiveness of chemical scavengers as therapeutics in organophosphate poisoning [PDF]

, 2017
Cholinergic crisis triggered by inhibition of cholinesterases via organophosphorus nerve agents (OP) and pesticides is treated with atropine and a reactivator of inhibited cholinesterase, called oxime.
Bierwisch, Anne
core  

Advancements in Virtual Bioequivalence: Computational Methods and Regulatory Perspectives in the Pharmaceutical Industry

Background/Objectives: The rise of virtual bioequivalence studies has transformed the pharmaceutical landscape, enabling more efficient drug development processes. This systematic review aims to explore advancements in Physiologically-Based Pharmacokinetic (PBPK) modeling, its regulatory implications, and its role in achieving virtual bioequivalence ...
Nasser Alotaiq, Doni Dermawan
openaire   +1 more source

Clinical Trial 2.0: Can Health 2.0 Transform the FDA Drug Approval Process? [PDF]

, 2012
Historically, patient activism has played a great part in shaping the drug approval process. Today, aided by developing web technologies, patients are once again seeking increased involvement in their medical care.
Atanassova, Mira
core  

EURL ECVAM Status Report on the Development, Validation and Regulatory Acceptance of Alternative Methods and Approaches (2013-April 2014) [PDF]

, 2014
The EURL ECVAM status report provides an update on the progress made in the development, validation and regulatory acceptance of alternative methods and approaches since the last report published in April 2013.
BERGGREN ELISABET, BERNASCONI Camilla, BESSEMS JOSEPH, CASATI Silvia, COECKE Sandra, CORVI Raffaella, DESPREZ BERTRAND, GRIESINGER Claudius, HALDER MARIA ELISABETH, JANUSCH ROI Annett, LANDESMANN Brigitte, MADIA FEDERICA, MILCAMPS Anne, MUNN SHARON, PRICE Anna, PRIETO PERAITA Maria Del Pilar, SCHAEFFER MICHAEL WILHELM, VIEGAS BARROSO JOAO FILIPE, WHELAN Maurice, WITTWEHR Clemens, WORTH Andrew, ZUANG Valerie   +21 more
core   +1 more source

Integrating Clinical Variability into PBPK Models for Virtual Bioequivalence of Single and Multiple Doses of Tofacitinib Modified‐Release Dosage Form

Clinical Pharmacology & Therapeutics
Tofacitinib is a potent, selective inhibitor of the Janus kinase (JAK) family of kinases with a high degree of selectivity within the human genome's set of protein kinases. Currently approved formulations for tofacitinib citrate are immediate‐release (IR) tablets, modified‐release (MR) tablets, and IR solution.
Vivek Purohit, Kazuko Sagawa, Hao‐Jui Hsu, Joseph Kushner, Martin E. Dowty, Susanna Tse, Jian Lin, Andrew Blanchard, Arnab Mukherjee, Vu Le, Cheng Chang   +10 more
openaire   +2 more sources