The Biowaiver Extension for BCS Class III Drugs: The Effect of Dissolution Rate on the Bioequivalence of BCS Class III Immediate-Release Drugs Predicted by Computer Simulation-Reference-Cited by-同舟云学术

The Biowaiver Extension for BCS Class III Drugs: The Effect of Dissolution Rate on the Bioequivalence of BCS Class III Immediate-Release Drugs Predicted by Computer Simulation

Published:2010-06-28 Issue:4 Volume:7 Page:1235-1243
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Tsume Yasuhiro¹,Amidon Gordon L.¹

Affiliation:

1. College of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109-1065

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/mp100053q

Reference40 articles.

1. The Suitability of an in Situ Perfusion Model for Permeability Determinations: Utility for BCS Class I Biowaiver Requests

2. The influence of the interdigestive migrating myoelectric complex on the gastric emptying of liquids

3. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System;U.S. Department of Health and Human Services, Food and Drug Administration, Center for Evaluation and Research: 2000.

4. DrugBank.

5. Guideline on the investigation of bioequivalence;EMA: 2010.

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