Results 91 to 100 of about 278 (111)

Improving In Vitro-In Vivo Correlation (IVIVC) for Lipid-Based Formulations: Overcoming Challenges and Exploring Opportunities. [PDF]

Pharmaceutics
Bourderi-Cambon A, Fadhlaoui K, Garrait G, Lainé E, Dhifallah I, Rossano M, Caisse P, Beyssac E.   +7 more
europepmc   +1 more source

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
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PBBMの現状について：審査当局の視点から

PBBMの現状について：審査当局の視点から
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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

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.
Rajkumar Boddu, Sivacharan Kollipara, Adithya Karthik Bhattiprolu   +2 more
exaly   +3 more sources

Best Practices for Integration of Dissolution Data into Physiologically Based Biopharmaceutics Models (PBBM): A Biopharmaceutics Modeling Scientist Perspective

AAPS PharmSciTech, 2023
Dissolution is considered as a critical input into physiologically based biopharmaceutics models (PBBM) as it governs in vivo exposure. Despite many workshops, initiatives by academia, industry, and regulatory, wider practices are followed for dissolution data input into PBBM models.
Sivacharan Kollipara, Adithya Karthik Bhattiprolu, Rajkumar Boddu   +2 more
exaly   +3 more sources

Applications of PBPK/PBBM modeling in generic product development: An industry perspective

Journal of Drug Delivery Science and Technology, 2022
Sivacharan Kollipara, Tausif Ahmed
exaly   +2 more sources

An Enabling Formulation of a Weakly Basic Compound Guided by Physiologically Based Biopharmaceutics Modeling (PBBM)

Journal of Pharmaceutical Sciences, 2022
Weakly basic compounds propose biopharmaceutics risks due to the possibility of precipitation out of solution when passing from the stomach to the intestine. This behavior would limit the available drug for absorption and in turn reduces the plasma exposure at dose escalation scenarios in phase 1 clinical trials.
Fady Ibrahim
exaly   +3 more sources

Power of integrating PBPK with PBBM (PBPK-BM): a single model predicting food effect, gender impact, drug-drug interactions and bioequivalence in fasting & fed conditions

Xenobiotica, 2023
Over the past few years, PBPK and PBBM modelling have proven their significance in drug development. PBPK modelling is traditionally used to predict drug-drug interactions, exposures in special populations whereas PBBM modelling is a part of PBPK modelling that is used for a range of biopharmaceutics applications.Because of these differences in ...
Rajkumar Boddu, Sivacharan Kollipara, Tausif Ahmed   +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