Results 111 to 120 of about 455 (133)

PBBMの現状について：審査当局の視点から

Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics
openaire   +3 more sources

PBBM tunjang pembangunan negara

, 2012
Anon
core  

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report

Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report
openaire   +1 more source

PBBM\u27s narrative trap

Teehankee, Julio C.
core  

国内におけるPBBM活用の現状と課題 ― 製薬企業アンケート調査結果から

Annual Scientific Meeting of The Japanese Society of Clinical Pharmacology and Therapeutics
openaire   +1 more source

Novel application of PBBM to justify impact of faster dissolution on safety and pharmacokinetics – a case study and utility in regulatory justifications

Xenobiotica, 2023
Physiologically based biopharmaceutics modelling (PBBM) was recognised as potential approach for biopharmaceutics applications. However, PBBM to justify safety is an unexplored area.In this manuscript, we elucidated PBBM application for safety justification.
Tausif Ahmed, Sivacharan Kollipara, Rajkumar Boddu   +2 more
exaly   +4 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 ...
Jennifer Dressman, Atsushi Kambayashi
exaly   +4 more sources

Establishing the Bioequivalence Safe Space for Immediate-Release Oral Dosage Forms using Physiologically Based Biopharmaceutics Modeling (PBBM): Case Studies

Journal of Pharmaceutical Sciences, 2021
For oral drug products, in vitro dissolution is the most used surrogate of in vivo dissolution and absorption. In the context of drug product quality, safe space is defined as the boundaries of in vitro dissolution, and relevant quality attributes, within which drug product variants are expected to be bioequivalent to each other.
Tausif Ahmed, Sandra Suarez-Sharp, Sivacharan Kollipara   +2 more
exaly   +4 more sources

A physiologically based biopharmaceutics modeling (PBBM) framework for characterizing formulation-dependent food effects: Paving the road towards fed state virtual BE studies for itraconazole amorphous solid dispersions

European Journal of Pharmaceutical Sciences
This study leverages physiologically based biopharmaceutics modeling (PBBM) to predict the clinical performance of two itraconazole (ITRA) amorphous solid dispersions (ASDs), Sempera® and Tolsura®, under fasted and fed state conditions, exploring the potential of PBBM in predicting formulation-specific food interactions.
Niklas, Rudolph, Nitin, Charbe, David, Plano, Abdullah Al, Shoyaib, Arindom, Pal, Heather, Boyce, Liang, Zhao, Fang, Wu, James, Polli, Jennifer, Dressman, Rodrigo, Cristofoletti   +10 more
exaly   +4 more sources

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Current State and Challenges of Physiologically Based Biopharmaceutics Modeling (PBBM) in Oral Drug Product Development

Pharmaceutical Research, 2022
Physiologically based biopharmaceutics modeling (PBBM) emphasizes the integration of physicochemical properties of drug substance and formulation characteristics with system physiological parameters to predict the absorption and pharmacokinetics (PK) of a drug product.

exaly   +3 more sources