Confidence in generic drug substitution

Clinical Pharmacology and Therapeutics

Volumn 94, Issue 4, 2013, Pages 438-440

  Lionberger, R ^a   Jiang, W ^a   Huang, S M ^b   Geba, G ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Center for Drug Evaluation and Research   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

GABAPENTIN; GENERIC DRUG; LAMOTRIGINE; TACROLIMUS;

BIOEQUIVALENCE; DRUG ABSORPTION; DRUG EXPOSURE; DRUG SUBSTITUTION; EPILEPSY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; KIDNEY TRANSPLANTATION; LIVER TRANSPLANTATION; NETHERLANDS; PRIORITY JOURNAL; REVIEW; UNITED STATES;

DRUGS, GENERIC; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 84884475913     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2013.104     Document Type: Review

References (9)

1. IMS Institute for Healthcare Informatics. Generic drug savings in the U.S. http://www.gphaonline.org/media//cms/IMSStudyAug2012WEB.pdf (2012).
2. Shrank, W.H. et al. State generic substitution laws can lower drug outlays under Medicaid. Health Affairs 29, 1383-1390 (2010).
3. Yu, Y., Teerenstra, S., Vanmolkot, F., Neef, C., Burger, D. & Maliepaard, M. Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study. Clin. Pharmacol. Ther. 94, 519-524 (2013).
4. Davit, B. Highly variable drugs: FDA case studies. Presented at the April 2004 FDA Advisory Committee for Pharmaceutical Sciences http://www.fda.gov/ ohrms/dockets/ac/04/slides/4034S2-06-Davit.ppt (14 April 2004)
5. Davit, B.M. et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann. Pharmacother. 43, 1583-1597 (2009).
6. Anderson, S. & Hauck, W.W. The transitivity of bioequivalence testing: potential for drift. Int. J. Clin. Pharmacol. Ther. 34, 369-374 (1996). (Pubitemid 26305808)
7. Maliepaard, M., Banishki, N., Gispen-de Wied, C.C., Teerenstra, S. & Elferink, A.J. Interchangeability of generic anti-epileptic drugs: a quantitative analysis of topiramate and gabapentin. Eur. J. Clin. Pharmacol. 67, 1007-1016 (2011).
8. Benet, L.Z. Bioequivalence of highly variable (HV) drugs: clinical implications why HV drugs are safer. Presented at the April 2004 FDA Advisory Committee for Pharmaceutical Sciences http://www.fda.gov/ohrms/dockets/ac/04/ slides/4034S2-04-Benet.ppt (14 April 2004).
9. US Food and Drug Administration. Draft guidance on warfarin sodium http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM201283.pdf (December 2012).