Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop-Reference-Cited by-同舟云学术

Model-Informed Drug Development and Review for Generic Products: Summary of FDA Public Workshop

Published:2018-03-30 Issue:1 Volume:104 Page:27-30
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Fang Lanyan¹,Kim Myong-Jin¹,Li Zhichuan¹,Wang Yaning²,DiLiberti Charles E.³,Au Jessie⁴,Hooker Andrew⁵,Ducharme Murray P.⁶,Lionberger Robert¹,Zhao Liang¹

Affiliation:

1. Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration; Silver Spring Maryland USA

2. Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration; Silver Spring Maryland USA

3. Montclair Bioequivalence Services, LLC; Montclair New Jersey USA

4. Optimum Therapeutics LLC; Carlsbad California USA

5. Department of Pharmaceutical Biosciences; Uppsala University; Uppsala Sweden

6. Learn and Confirm Inc.; Bois Franc St-Laurent Canada

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference10 articles.

1. Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review Public Workshop https://www.fda.gov/Drugs/NewsEvents/ucm554182.htm 2017

2. Gottlieb , S Remarks by Scott Gottlieb, M.D. on Leveraging Quantitative Methods and Modeling to Modernize Generic Drug Development and Review https://www.fda.gov/NewsEvents/Speeches/ucm578381.htm 2017

3. Gottlieb , S FDA Working to Lift Barriers to Generic Drug Competition https://blogs.fda.gov/fdavoice/index.php/2017/06/fda-working-to-lift-barriers-to-generic-drug-competition/ 2017

4. Gonzalez-Sales , M et al Age is a statistically significant predictor of the within subject variability in dabigatran pharmacokinetics

5. Product Specific Guidance on Dabigatran Etexilate Mesylate https://www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM308030.pdf

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