Is Bioequivalence Established Based on the Reference‐Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin? Perspectives Based on Population Pharmacokinetic Modeling and Simulations-Reference-Cited by-同舟云学术

Is Bioequivalence Established Based on the Reference‐Scaled Average Bioequivalence Approach Relevant to Chronic Administration of Phenytoin? Perspectives Based on Population Pharmacokinetic Modeling and Simulations

Published:2019-02-04 Issue:8 Volume:59 Page:1061-1069
ISSN:0091-2700
Container-title:The Journal of Clinical Pharmacology
language:en
Short-container-title:The Journal of Clinical Pharmacology

Author:

Kim Hyewon¹,Fang Lanyan¹,Yu Jingyu²,Meng Zhaoyu³,Trame Mirjam N.³,Schmidt Stephan³,Lesko Lawrence J.³,Zhao Liang¹

Affiliation:

1. Office of Research and StandardsOffice of Generic DrugsCenter for Drug Evaluation and ResearchFood and Drug Administration Silver Spring MD USA

2. Office of Clinical PharmacologyOffice of Translational SciencesCenter for Drug Evaluation and ResearchFood and Drug Administration Silver Spring MD USA

3. Center for Pharmacometrics and Systems PharmacologyDepartment of PharmaceuticsCollege of PharmacyUniversity of Florida Orlando, FL USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/jcph.1380

Reference23 articles.

1. Title 21 Code of Federal Regulations Section 314.3.

2. Guidance for Industry:bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA. December2013.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377465.pdf. Accessed December 17 2018.

3. Novel bioequivalence approach for narrow therapeutic index drugs

4. Draft guidance on warfarin sodium. December 2012.https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201283.pdf. Accessed December 17 2018.

5. Draft guidance on phenytoin sodium extended release capsule.December 2014.http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM428265.pdf. Accessed December 17 2018.

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