Quality of reporting of bioequivalence trials comparing generic to brand name drugs: A methodological systematic review

PLoS ONE

Volumn 6, Issue 8, 2011, Pages

  van der Meersch, Amélie ^a,b,c   Dechartres, Agnès ^a,b,c   Ravaud, Philippe ^a,b,c  

^a INSERM   (France)

^b HÔTEL DIEU   (France)

^c UNIVERSITÉ PARIS DESCARTES   (France)

Author keywords

[No Author keywords available]

Indexed keywords

GENERIC DRUG; DRUG;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CLINICAL PROTOCOL; COST EFFECTIVENESS ANALYSIS; DOSE RESPONSE; DRUG COST; DRUG EFFICACY; FUNDING; HEALTH CARE FINANCING; HUMAN; INFORMATION PROCESSING; MAXIMUM PLASMA CONCENTRATION; QUALITY CONTROL; REPEATED DRUG DOSE; REVIEW; SINGLE DRUG DOSE; STUDY DESIGN; SYSTEMATIC REVIEW; TOTAL QUALITY MANAGEMENT; VALIDATION PROCESS; DRUG APPROVAL; EUROPE; FOOD AND DRUG ADMINISTRATION; LEGAL ASPECT; METABOLISM; ORGANIZATION AND MANAGEMENT; PHARMACOKINETICS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RESEARCH; STANDARD; UNITED STATES;

DRUG APPROVAL; DRUGS, GENERIC; EUROPE; HUMANS; PHARMACEUTICAL PREPARATIONS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH REPORT; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 80051826982     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0023611     Document Type: Review

References (23)

1. Frank RG, (2007) The ongoing regulation of generic drugs. N Engl J Med 357: 1993-1996.
2. FDA Guidance for Industry- Bioavailability and Bioequivalence Studies for Orally Administered Drugs Products- General Considerations. Available:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulator yInformation/Guidances/ucm070124.pdf. Assessed 2011Jul 25.
3. EMEA Committee for medicinal products for human use (CMPH) Guideline on the investigation of bioequivalence. Available: http://www.ema.europa.eu/pdfs/human/qwp/140198enrev1fin.pdf Assessed 2011 Jul 25.
4. Lesser RP, Krauss G, (2001) Buy some today: can generics be safely substituted for brand-name drugs? Neurology 57: 571-573.
5. Borgheini G, (2003) The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther 25: 1578-1592.
6. Mastoraki E, Michalopoulos A, Kriaras I, Mouchtouri E, Falagas M, et al. (2008) Incidence of postoperative infections in patients undergoing coronary artery bypass grafting surgery receiving antimicrobial prophylaxis with original and generic cefuroxime. J Infect 56: 35-39.
7. Sabatini S, Ferguson RM, Helderman JH, Hull AR, Kirkpatrick BS, et al. (1999) Drug substitution in transplantation: a National Kidney Foundation White Paper. Am J Kidney Dis 33: 389-397.
8. Wassef AA, Winkler DE, Roache AL, Abobo VB, Lopez LM, et al. (2005) Lower effectiveness of divalproex versus valproic acid in a prospective, quasi-experimental clinical trial involving 9,260 psychiatric admissions. Am J Psychiatry 162: 330-339.
9. Wilner AN, (2004) Therapeutic equivalency of generic antiepileptic drugs: results of a survey. Epilepsy Behav 5: 995-998.
10. McCartney M, (2010) Generic drugs: protest group was not quite what it seemed. BMJ 340: c1514.
11. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, et al. (2008) Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 300: 2514-2526.
12. Kesselheim AS, Stedman MR, Bubrick EJ, Gagne JJ, Misono AS,et al. Seizure outcomes following the use of generic versus brand-name antiepileptic drugs: a systematic review and meta-analysis. Drugs 70: 605-621.
13. WHO Anatomical Therapeutic Chemical classification system with defined daily doses (ATC DDD) Family of international classifications.
14. CFR code of federal regulation Bioavailability and bioequivalence requirement. Available http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr =320.33. Assessed 2011 Jul 25.
15. Higgins JPT, Green S, eds. (2008) Cochrane handbook for systematic reviews of interventions version 5.0.0. Cochrane Collaboration.
16. Le Henanff A, Giraudeau B, Baron G, Ravaud P, (2006) Quality of reporting of noninferiority and equivalence randomized trials. JAMA 295: 1147-1151.
17. Wangge G, Klungel OH, Roes KC, de Boer A, Hoes AW, et al. Room for improvement in conducting and reporting non-inferiority randomized controlled trials on drugs: a systematic review. PLoS One 5: e13550.
18. FDA Drug approval reports. Available: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseacti on=Reports.ReportsMenu. Assessed 2011 Jul 25.
19. Dickersin K, (1990) The existence of publication bias and risk factors for its occurrence. JAMA 263: 1385-1389.
20. D'Agostino RB Sr, Massaro JM, Sullivan LM, (2003) Non-inferiority trials: design concepts and issues- the encounters of academic consultants in statistics. Stat Med 22: 169-186.
21. Djulbegovic B, Clarke M, (2001) Scientific and ethical issues in equivalence trials. JAMA 285: 1206-1208.
22. Walker SE, Friesen MH, (1999) Are the current bioequivalence standards sufficient for the acceptance of narrow therapeutic index drugs? Utilization of a computer simulated warfarin bioequivalence model. J Pharm Pharm Sci 2: 15-22.
23. Yim DS, (2009) Simulation of the AUC changes after generic substitution in patients. J Korean Med Sci 24: 7-12.