Novel bioequivalence approach for narrow therapeutic index drugs

Author:

Yu LX1,Jiang W1,Zhang X1,Lionberger R1,Makhlouf F1,Schuirmann DJ1,Muldowney L1,Chen M-L1,Davit B12,Conner D1,Woodcock J1

Affiliation:

1. Center for Drug Evaluation and Research; US Food and Drug Administration; Silver Spring Maryland USA

2. Merck Research Laboratories; Whitehouse Station New Jersey USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Reference28 articles.

1. IMS Institute for Healthcare Informatics Declining medicine use and costs: for better or worse? A review of the use of medicines in the United States in 2012 http://static.correofarmaceutico.com/docs/2013/05/20/usareport.pdf 2013

2. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability;Schuirmann;J. Pharmacokinet. Biopharm.,1987

3. US Food and Drug Administration Center for Drug Evaluation and Research Orange book - Approved drug products with therapeutic equivalence evaluations, section 1.3 Statistical Criteria for Bioequivalence, 33rd ed http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf 2013

4. US Food and Drug Administration April 13, 2010 Meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee: Topic 1, Revising the BE approaches for critical dose drugs http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AdvisoryCommitteeforPharmaceuticalScienceandClinical Pharmacology/ucm209318.htm 2010

5. US Food and Drug Administration Draft guidance on warfarin sodium http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM201283.pdf 2012

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