In Vitro Predictive Dissolution Test Should Be Developed and Recommended as a Bioequivalence Standard for the Immediate-Release Solid Oral Dosage Forms of the Highly Variable Mycophenolate Mofetil-Reference-Cited by-同舟云学术

In Vitro Predictive Dissolution Test Should Be Developed and Recommended as a Bioequivalence Standard for the Immediate-Release Solid Oral Dosage Forms of the Highly Variable Mycophenolate Mofetil

Published:2022-05-23 Issue:7 Volume:19 Page:2048-2060
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Wang Kai¹^ORCID,Li Yangbing²,Chen Bing³,Chen Hao⁴,Smith David E.¹,Sun Duxin¹^ORCID,Feng Meihua R.¹,Amidon Gordon L.¹^ORCID

Affiliation:

1. Department of Pharmaceutical Sciences, University of Michigan, Ann Arbor, Michigan 48109, United States

2. Department of Medicinal Chemistry, University of Michigan, Ann Arbor, Michigan 48109, United States

3. Department of Pharmacy, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China

4. Center of Organ Transplantation and Department of Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.molpharmaceut.1c00792

Reference50 articles.

1. Bio-International 92, Conference on Bioavailability, Bioequivalence, and Pharmacokinetic Studies

2. Bioequivalence Testing -- A Need to Rethink

3. Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

4. SUPAC-IR: Immediate-Release Solid Oral Dosage Forms: Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. https://www.fda.gov/media/70949/download (accessed April 5, 2022).

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