Healthy User Bias in Comparative Safety Studies for Brand‐Name vs. Generic Products: The Example of Warfarin-Reference-Cited by-同舟云学术

Healthy User Bias in Comparative Safety Studies for Brand‐Name vs. Generic Products: The Example of Warfarin

Published:2019-07 Issue:5 Volume:106 Page:1037-1045
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Bird Steven T.¹,Flowers Natasha²,Zhao Yueqin³,McKean Stephen²,Izem Rima³,Wernecke Michael²,Kozlowski Steven⁴,MaCurdy Thomas E.²⁵,Kelman Jeffrey A.⁶,Graham David J.¹

Affiliation:

1. Office of Surveillance and EpidemiologyUS Food and Drug Administration Silver Spring Maryland USA

2. Acumen, LLC Washington DC USA

3. Office of BiostatisticsCenter for Drug Evaluation and ResearchUS Food and Drug Administration Silver Spring Maryland USA

4. Office of Pharmaceutical QualityUS Food and Drug Administration Silver Spring Maryland USA

5. Department of EconomicsStanford University Stanford California USA

6. Centers for Medicare & Medicaid Services Baltimore Maryland USA

Funder

U.S. Food and Drug Administration

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1498

Reference27 articles.

1. US Food and Drug Administration (FDA).FDA fact sheet; what's involved in reviewing and approving generic drug applications?https://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/UCM510852.pdf> (2017). Accessed March 19 2019.

2. North Carolina Board of Pharmacy laws of North Carolina.Pharmacy laws of North Carolina (2018). Accessed August 11 2018.

3. Drug products with therapeutic problems.Kentucky Legislature (2018). Accessed August 11 2018.

4. Withdrawal of Generic Budeprion for Nonbioequivalence

5. US Food and Drug Administration (FDA).Methylphenidate hydrochloride extended release tablets (generic Concerta) made by Mallinckrodt and Kudco (2016). Accessed August 11 2018.

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1. Structural Changes of Sodium Warfarin in Tablets Affecting the Dissolution Profiles and Potential Safety of Generic Substitution;Pharmaceutics;2021-08-30

2. Comparative Outcomes of Treatment Initiation With Brand vs. Generic Warfarin in Older Patients;Clinical Pharmacology & Therapeutics;2020-01-19