AREA UNDER THE CURVE;
BIOEQUIVALENCE;
COST BENEFIT ANALYSIS;
COST CONTROL;
CYP2C19 GENE;
DRUG APPROVAL;
DRUG BLOOD LEVEL;
DRUG COST;
DRUG EFFICACY;
DRUG FORMULATION;
DRUG INFORMATION;
DRUG MANUFACTURE;
DRUG MARKETING;
DRUG METABOLISM;
DRUG SAFETY;
GENETIC RISK;
GENOTYPE;
HUMAN;
MAXIMUM PLASMA CONCENTRATION;
PRIORITY JOURNAL;
SHORT SURVEY;
ARTICLE;
CHEMISTRY;
CLINICAL PRACTICE;
DRUG SUBSTITUTION;
ECONOMICS;
FOOD AND DRUG ADMINISTRATION;
THERAPEUTIC EQUIVALENCE;
UNITED STATES;
CHEMISTRY, PHARMACEUTICAL;
COST SAVINGS;
DRUG APPROVAL;
DRUG COSTS;
DRUG SUBSTITUTION;
DRUGS, GENERIC;
HUMANS;
PHYSICIAN'S PRACTICE PATTERNS;
PLATELET AGGREGATION INHIBITORS;
THERAPEUTIC EQUIVALENCY;
TICLOPIDINE;
UNITED STATES;
UNITED STATES FOOD AND DRUG ADMINISTRATION;
Associated Press. February 8, Accessed June 4, 2013
Associated Press. Apotex pays Bristol, Sanofi damages over Plavix. Wall Street Journal. February 8, 2012. http://online.wsj.com/article/ AP1014976e51794b219c841c152ddc9f8e.html. Accessed June 4, 2013.
A randomized comparison of platelet reactivity in patients after treatment with various commercial clopidogrel preparations: The CLO-CLO trial
Oberhänsli M, Lehner C, Puricel S, et al. A randomized comparison of platelet reactivity in patients after treatment with various commercial clopidogrel preparations: the CLO-CLO trial. Arch Cardiovasc Dis. 2012;105(11):587-592.
US Food and Drug Administration (FDA). 29th ed. website. Accessed June 4, 2013
US Food and Drug Administration (FDA). Approved Products With Therapeutic Equivalence Evaluations. 29th ed. FDA website. www.fda.gov/Drugs/ DevelopmentApprovalProcess/ucm079068.htm. 2009. Accessed June 4, 2013.
Comparing generic and innovator drugs: A review of 12 years of bioequivalence data from the United States Food and Drug Administration
Davit BM, Nwakama PE, Buehler GJ, 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. 2009;43(10):1583-1597.
Quality of reporting of bioequivalence trials comparing generic to brand name drugs: A methodological systematic review
van der Meersch A, Dechartres A, Ravaud P. Quality of reporting of bioequivalence trials comparing generic to brand name drugs: a methodological systematic review. PLoS One. 2011;6(8):e23611.
Cardiovascular risk in clopidogrel-treated patients according to cytochrome P450 2C19*2 loss-of-function allele or proton pump inhibitor coadministration: A systematic meta-analysis
Hulot JS, Collet JP, Silvain J, et al. Cardiovascular risk in clopidogrel-treated patients according to cytochrome P450 2C19*2 loss-of-function allele or proton pump inhibitor coadministration: a systematic meta-analysis. J Am Coll Cardiol. 2010;56(2):134-143.
Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet function
Frelinger AL 3rd, Bhatt DL, Lee RD, et al. Clopidogrel pharmacokinetics and pharmacodynamics vary widely despite exclusion or control of polymorphisms (CYP2C19, ABCB1, PON1), noncompliance, diet, smoking, co-medications (including proton pump inhibitors), and pre-existent variability in platelet function. J Am Coll Cardiol. 2013;61(8):872-879.
US Food and Drug Administration (FDA). website. Accessed June 4, 2013
US Food and Drug Administration (FDA). FDA Drug Safety Communication: Reduced Effectiveness of Plavix (Clopidogrel) in Patients Who Are Poor Metabolizers of the Drug. FDA website. www.fda.gov/drugs/drugsafety/ postmarketdrugsafetyinformationforpatientsandproviders/ucm203888.htm. Accessed June 4, 2013.
