Results 61 to 70 of about 690 (120)

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

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

Approaches to conducting a physiologically relevant test (PRT) in the study of medicines containing substance IIc of the BCS subclass using sorafenib as an example

Разработка и регистрация лекарственных средств
Introduction. Sorafenib is an antineoplastic drug belonging to class IIc according to the biopharmaceutical classification system (BCS) due to the presence of both acidic and basic properties.
A. V. Suvorova, Yu. V. Medvedev, P. A. Losenkova, O. S. Kramarenko, E. A. Malashenko, A. M. Poluyanov, I. E. Shohin   +6 more
doaj   +1 more source

Demonstration of in vitro-in vivo relationship (IVIVR) and virtual bioequivalence (VBE) between progesterone intravaginal rings using physiologically based pharmacokinetic (PBPK) modelling

Journal of Pharmaceutical Sciences
The vaginal route of administration enables convenient local and systemic drug delivery with the avoidance of hepatic first-pass metabolism. Considering the clinical advantages of vaginal delivery, development of physiologically based pharmacokinetic (PBPK) models of vaginal absorption to inform drug and formulation development is deemed valuable.
Kanika Thakur, Ola Sternebring, Yu-E Zhang, Kevin Wyckoff, Iain Macdonald, Philippe Pinton, Daniel Paterson, Krishna Chaitanya Telaprolu, Sebastian Polak   +8 more
openaire   +3 more sources

Establishing virtual bioequivalence and bio-related dissolution specifications for naproxen using physiologically based pharmacokinetic modeling and in vitro biorelevant dissolution testing

Drug Development and Industrial Pharmacy
The aim of the present study was to assess the accuracy of the PBPK model in predicting the pharmacokinetic behavior of weakly acidic BCS class II drugs in humans through a multipronged approach of in vitro dissolution, in vivo studies, and in silico simulations.
Chenxia, Bai, Jiaming, Zhang, Xiaolan, Xu, Xiaoting, Li, Tianhong, Zhang   +4 more
openaire   +2 more sources

Virtual Trial Comparisons and Bioequivalence Assessment: From Data-Based to Probabilistic Assessment

The recent emergence of virtual comparative trials, in particular for virtual bioequivalence (VBE) assessment, implies a formalization of their analyses. In recent VBE assessments, pharmacokinetic models informed with in vitro data and verified with small clinical trials data were used to simulate otherwise unfeasibly large trials. Simulated VBE trials
Brochot, Céline, Bois, Frederic Yves
openaire   +1 more source

Correct Statistical Inference from Simulated Clinical Trials: Meta-modeling and Statistical Assurance for Virtual Bioequivalence Assessments Using PBPK Models

We show that correct statistical inference from simulated virtual clinical trials requires a Bayesian framework. Simulating frequentist test procedures degrades the prior information contained in the model. We demonstrate the application of a Bayesian workflow to PBPK-simulated virtual bioequivalence trials.
openaire   +3 more sources

Model-Integrated Bioequivalence (MIBE) in Generic Drug Research: Can We Ease the Bioequivalence Burden? [PDF]

Pharmaceutics
Kollipara S, Boddu R, Uppuluri CT, Saini AK.   +3 more
europepmc   +1 more source

Guiding a Diclofenac Sodium Dual-Release Sustained Formulation Development Through In Vitro-In Vivo Relationship Based on Physiologically Based Pharmacokinetics. [PDF]

Pharmaceutics
Wang Q, Guo P, Hu T, Li L, Zhu T, Pan Y, Xiang X, Wang J.   +7 more
europepmc   +1 more source

Effectiveness of virtual simulation-based pre-learning and the mediating role of metacognition in pharmacokinetics laboratory education. [PDF]

BMC Med Educ
Hu X, Liu J, Wang J.
europepmc   +1 more source