Results 111 to 120 of about 690 (120)

Utilizing Physiologically Based Pharmacokinetic Modeling and Virtual Simulation for Simvastatin Tablets to Evaluate the Sensitivity of Using Parent vs Metabolite as Analyte on Bioequivalence Assessment

The AAPS Journal
Typically, parent drug is measured for bioequivalence (BE) assessment because it's more sensitive to detect formulation differences, compared to its metabolite(s). For simvastatin immediate release (IR) tablets, current product-specific guidance (PSG) recommends measuring both parent and metabolite but taking metabolite as supportive data.
Yi-Hsien Cheng, Fang Wu, Miyoung Yoon, Liang Zhao, Lanyan Fang   +4 more
openaire   +2 more sources

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, Ji Jiang
exaly  

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

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

European Journal of Pharmaceutical Sciences, 2020
Rebeka Jereb, Amitava Mitra
exaly  

Integrated Pirana–Simcyp Virtual Bioequivalence converts PBPK simulations into rapid, reproducible, and extensible bioequivalence decisions

Craig, James, Morris, Natalie M., McNally, Kevin, Clairissa Corpstein, kRISHNA CHAITANYA Telaprolu, Bogdanovich, Pauline, Turner, David, Rostami-Hodjegan, Amin, Jamei, Masoud, Bois, Frederic Yves   +9 more
openaire   +1 more source

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

Successful bioequivalence prediction of immediate-release vortioxetine tablets through prospective virtual crossover and parallel trials

Journal of Pharmaceutical Sciences
Dorota Danielak, Marcela Staniszewska, Svitlana Romanova, Jadwiga Paszkowska, Justyna Dobosz, Daria Myslitska, Michał Smoleński, Jarosław Pieczuro, Dagmara Roznerska, Janusz Szczepański, Michał Schraube, Ewa Puk, Oksana Hrem, Grzegorz Garbacz, Michał Romański   +14 more
openaire   +1 more source

Bioequivalence

2022
exaly