Some thoughts on drug interchangeability. 2016

Shein-Chung Chow, and Fuyu Song, and Meng Chen
a Department of Biostatistics and Bioinformatics, Duke University School of Medicine , Durham , North Carolina , USA.

Current regulation for generic approval is based on the assessment of average bioequivalence. As indicated by the United States Food and Drug Administration (FDA), an approved generic drug can be used as a substitute for the innovative drug. FDA does not indicate that two generic copies of the same innovative drug can be used interchangeably even though they are bioequivalent to the same brand-name drug. In practice, bioequivalence between generic copies of an innovative drug is not required. However, as more generic drug products become available, it is a concern whether the approved generic drug products have the same quality and therapeutic effect as the brand-name drug product and whether they can be used safely and interchangeably. In this article, several criteria including a newly proposed criterion for assessing drug interchangeability are studied. In addition, comments on possible study designs and power calculation for sample size under a specific design are also discussed.

UI MeSH Term Description Entries
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013810 Therapeutic Equivalency The relative equivalency in the efficacy of different modes of treatment of a disease, most often used to compare the efficacy of different pharmaceuticals to treat a given disease. Bioequivalence,Clinical Equivalency,Equivalency, Therapeutic,Generic Equivalency,Clinical Equivalencies,Equivalencies, Clinical,Equivalencies, Therapeutic,Equivalency, Clinical,Therapeutic Equivalencies,Bioequivalences,Equivalencies, Generic,Equivalency, Generic,Generic Equivalencies
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D014486 United States Food and Drug Administration An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc. Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D016568 Drugs, Generic Drugs whose drug name is not protected by a trademark. They may be manufactured by several companies. Drugs, Nonproprietary,Generic Drug,Generic Drugs,Drug, Generic,Nonproprietary Drugs
D017277 Drug Approval Process that is gone through in order for a drug to receive approval by a government regulatory agency. This includes any required pre-clinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance of the drug. Drug Approval Process,New Drug Approval,Food and Drug Administration Drug Approval,Food and Drug Administration Drug Approval Process,New Drug Approval Process,Approval Process, Drug,Approval Processes, Drug,Approval, Drug,Approval, New Drug,Approvals, Drug,Approvals, New Drug,Drug Approval Processes,Drug Approval, New,Drug Approvals,Drug Approvals, New,New Drug Approvals,Process, Drug Approval,Processes, Drug Approval
D057915 Drug Substitution The practice of replacing one prescribed drug with another that is expected to have the same clinical or psychological effect. Drug Switching,Generic Substitution,Therapeutic Substitution,Drug Substitutions,Drug Switchings,Generic Substitutions,Substitution, Drug,Substitution, Generic,Substitution, Therapeutic,Substitutions, Drug,Substitutions, Generic,Substitutions, Therapeutic,Switching, Drug,Switchings, Drug,Therapeutic Substitutions
D059451 Biosimilar Pharmaceuticals Biological products that are imitations but not exact replicas of innovator biological products. Biosimilar,Biosimilars,Follow-on Biologics,Subsequent Entry Biologics,Biologics, Follow-on,Biologics, Subsequent Entry,Follow on Biologics,Pharmaceuticals, Biosimilar

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