Results 101 to 110 of about 690 (120)

In Silico Modeling and Simulation to Guide Bioequivalence Testing for Oral Drugs in a Virtual Population

Clinical Pharmacokinetics, 2021
Model-informed drug discovery and development (MID3) shows great advantages in facilitating drug development. A physiologically based pharmacokinetic model is one of the powerful computational approaches of MID3, and the emerging field of virtual bioequivalence is well recognized to be the future of the physiologically based pharmacokinetic model ...
Fan Zhang, Ji Jiang
exaly   +3 more sources

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria

European Journal of Pharmaceutical Sciences, 2017
Majority of bioequivalence studies are conducted in healthy volunteers. It has been argued that bioequivalence may not necessarily hold true in relevant patient populations due to a variety of reasons which affect one formulation more than the other for instance in achlorhydric patients where elevated gastric pH may lead to differential effects on ...
Kosuke Doki, Adam S Darwich, Nikunjkumar Patel   +2 more
exaly   +3 more sources

Establishing virtual bioequivalence and clinically relevant specifications using in vitro biorelevant dissolution testing and physiologically-based population pharmacokinetic modeling. case example: Naproxen [PDF]

European Journal of Pharmaceutical Sciences, 2020
Physiologically-based population pharmacokinetic modeling (popPBPK) coupled with in vitro biopharmaceutics tools such as biorelevant dissolution testing can serve as a powerful tool to establish virtual bioequivalence and set clinically relevant specifications.
Ioannis Loisios-Konstantinidis, Rodrigo Cristofoletti, Nikoletta Fotaki   +2 more
exaly   +3 more sources

Conjunction of semi-mechanistic in vitro-in vivo modeling and population pharmacokinetics as a tool for virtual bioequivalence analysis - a case study for a BCS class II drug

European Journal of Pharmaceutics and Biopharmaceutics, 2023
Virtual bioequivalence trial (VBE) simulations based on (semi)mechanistic in vitro-in vivo (IVIV) modeling have gained a huge interest in the pharmaceutical industry. Sophisticated commercially available software allows modeling variable drug fates in the gastrointestinal tract (GIT).
Dorota Danielak, Jadwiga Paszkowska, Marcela Staniszewska   +2 more
exaly   +3 more sources

Towards Virtual Bioequivalence Studies for Oral Dosage Forms Containing Poorly Water-Soluble Drugs: A Physiologically Based Biopharmaceutics Modeling (PBBM) Approach

Journal of Pharmaceutical Sciences, 2022
The objective of the present study was to develop a physiologically based biopharmaceutics (PBBM) approach to predict the bioequivalence of dosage forms containing poorly soluble drugs. Aripiprazole and enzalutamide were used as model drugs. Variations in the gastrointestinal (GI) physiological parameters of fasted humans were taken into consideration ...
Atsushi Kambayashi, Jennifer B Dressman
exaly   +3 more sources

Predicting the Pharmacokinetics of Orally Administered Drugs across BCS Classes 1–4 by Virtual Bioequivalence Model

Molecular Pharmaceutics, 2022
To evaluate the influence of solubility and permeability on the pharmacokinetic prediction performance of orally administered drugs using avirtual bioequivalence (VBE) model, a total of 23 orally administered drugs covering Biopharmaceutics Classification System (BCS) classes 1-4 were selected. A VBE model (i.e., a physiologically based pharmacokinetic
Fan Zhang, Xiaofei Wu, Keheng Wu, Mengyang Yu, Bo Liu, Hongyun Wang   +5 more
openaire   +2 more sources

Virtual Bioequivalence Assessment of Tofacitinib Once Daily Modified Release Dosage Form in Pediatric Subjects

AAPS Journal
Abstract 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.
Kazuko Sagawa, Martin E Dowty, Cheng Chang   +2 more
exaly   +3 more sources

Virtual Bioequivalence Assessment of Ritlecitinib Capsules with Incorporation of Observed Clinical Variability Using a Physiologically Based Pharmacokinetic Model

AAPS Journal
AbstractRitlecitinib, an orally available Janus kinase 3 and tyrosine kinase inhibitor being developed for the treatment of alopecia areata (AA), is highly soluble across the physiological pH range at the therapeutic dose. As such, it is expected to dissolve rapidly in any in vitro dissolution conditions.
Martin E Dowty, Kazuko Sagawa
exaly   +3 more sources

Establishing Virtual Bioequivalence and Clinically Relevant Specifications for Omeprazole Enteric-Coated Capsules by Incorporating Dissolution Data in PBPK Modeling

The AAPS Journal
Currently, Biopharmaceutics Classification System (BCS) classes I and III are the only biological exemptions of immediate-release solid oral dosage forms eligible for regulatory approval. However, through virtual bioequivalence (VBE) studies, BCS class II drugs may qualify for biological exemptions if reliable and validated modeling is used.
Ruwei Yang, Yaqi Lin, Kaifeng Chen, Jie Huang, Shuang Yang, An Yao, Xiaoyan Yang, Deqing Lei, Jing Xiao, Guoping Yang, Qi Pei   +10 more
openaire   +2 more sources

VIRTUAL BIOEQUIVALENCE APPLICATIONS IN DRUGS

Objective: Virtual bioequivalence studies play a critical role in facilitating and optimizing drug development processes of new drugs and generic drugs. This approach relies on mathematical calculations to mimic and predict the behavior of drugs in the human body.
Gülsün, Tuğba, Demir, Huriye, Öner, Levent   +2 more
openaire   +1 more source