Application of physiologically based biopharmaceutics modeling to understand the impact of dissolution differences on in vivo performance of immediate release products: The case of bisoprolol

Author:

Macwan Joyce S.1,Fraczkiewicz Grace1,Bertolino Mauro2,Krüger Phillip3,Peters Sheila‐Annie2

Affiliation:

1. Simulations Plus, Inc Lancaster California USA

2. Quantitative Pharmacology Merck KGaA Darmstadt Germany

3. Manufacturing Science and Technology Merck KGaA Darmstadt Germany

Funder

Merck KGaA

Publisher

Wiley

Subject

Pharmacology (medical),Modelling and Simulation

Reference31 articles.

1. US Food and Drug Administration.Impact story: modeling tools could modernize generic drug development.https://www.fda.gov/drugs/regulatory‐science‐action/impact‐story‐modeling‐tools‐could‐modernize‐generic‐drug‐development. Accessed July 19 2020.

2. Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls: A Workshop Summary Report

3. Basic Pharmacokinetics of Bisoprolol, a New Highly Beta1-selective Adrenoceptor Antagonist

4. Balanced pharmacokinetics and metabolism of bisoprolol;Leopold G;J Cardiovasc Pharmacol,1986

5. Bisoprolol in Angina Pectoris

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