Results 141 to 150 of about 1,942 (154)

Assessment of Bioequivalence of Weak Base Formulations Under Various Dosing Conditions Using Physiologically Based Pharmacokinetic Simulations in Virtual Populations. Case Examples: Ketoconazole and Posaconazole

Journal of Pharmaceutical Sciences, 2017
Postabsorptive factors which can affect systemic drug exposure are assumed to be dependent on the active pharmaceutical ingredient (API), and thus independent of formulation. In contrast, preabsorptive factors, for example, hypochlorhydria, might affect systemic exposure in both an API and a formulation-dependent way.
Rodrigo, Cristofoletti, Nikunjkumar, Patel, Jennifer B, Dressman   +2 more
openaire   +2 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 Frameworks and Workflows

We are developing advanced virtual bioequivalence (VBE) assessment models and methods, with a focus on the fundamentals of decision workflows in that context.This presentation covers: VBE workflows Advanced long-acting injectable and oral absorption models Case studies overview Software ...
openaire   +1 more source

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

Virtual Workshop Report: Approaches, Regulatory Challenges, and Advances in Bioequivalence, Dissolution Testing, and Biowaivers: Manila, Philippines, February 22-24, 2023

Dissolution Technologies, 2023
James E. Polli, Vivian A. Gray, Willison John E. De Luna, Andreas Abend, Michael Daniel C. Lucagbo, Sandra Suarez-Sharp, Alicia P. Catabay, Leonel Santos, Bienvenido S. Balotro   +8 more
openaire   +1 more source

DISOPYRAMIDE PHOSPHATE AND BASE ARE ‘VIRTUALLY BIOEQUIVALENT’

InPharma, 1978
openaire   +1 more source

In silico prediction of bioequivalence of Isosorbide Mononitrate tablets with different dissolution profiles using PBPK modeling and simulation

European Journal of Pharmaceutical Sciences, 2021
Fan Zhang, Zhou Zhou
exaly  

Prediction of fasted and fed bioequivalence for immediate release drug products using physiologically based biopharmaceutics modeling (PBBM)

European Journal of Pharmaceutical Sciences, 2020
Jereb Rebeka
exaly  

PBPK-Based Virtual Bioequivalence Trials to Guide Drug Development

Amitava Mitra, Jim Mullin, Siri Kalyan Chirumamilla   +2 more
openaire   +1 more source

P.6.4 DEVELOPMENT OF A GENERATIVE ARTIFICIAL INTELLIGENCE ALGORITHM FOR THE REGENERATION OF VIRTUAL VOLUNTEERS IN BIOEQUIVALENCE STUDIES

Physica Medica
A. Nikolopoulos, V. Karalis
openaire   +1 more source