Bioequivalence requirements in the european union: Critical discussion

AAPS Journal

Volumn 14, Issue 4, 2012, Pages 738-748

  García Arieta, Alfredo ^a   Gordon, John ^b  

^a Department of Human Use Medicines   (Spain)

^b Division of Biopharmaceutics Evaluation   (Canada)

Author keywords

Bioequivalence; Generic medicinal products; Regulatory requirements

Indexed keywords

ALENDRONIC ACID; CYCLOSPORIN; DOXORUBICIN; DRUG METABOLITE; GENERIC DRUG; GLIMEPIRIDE; LOSARTAN; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; OMEPRAZOLE; RISPERIDONE;

AREA UNDER THE CURVE; BIOEQUIVALENCE; DIET RESTRICTION; DRUG ABSORPTION; DRUG CLASSIFICATION; DRUG DOSAGE FORM; DRUG POTENCY; DRUG SAFETY; DRUG SOLUBILITY; DRUG TOLERABILITY; ENANTIOMER; EUROPEAN UNION; FOOD AND DRUG ADMINISTRATION; HUMAN; IN VITRO STUDY; LEGAL ASPECT; MAXIMUM PLASMA CONCENTRATION; PHARMACODYNAMICS; PRACTICE GUIDELINE; REVIEW; STANDARDIZATION; TIME TO MAXIMUM PLASMA CONCENTRATION; UNITED STATES;

DRUG DESIGN; DRUGS, GENERIC; EUROPEAN UNION; EXCIPIENTS; GUIDELINES AS TOPIC; HUMANS; PHARMACEUTICAL PREPARATIONS; SOLUBILITY; THERAPEUTIC EQUIVALENCY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84869099630     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/s12248-012-9382-1     Document Type: Review

References (40)

1. U.S. Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance for Industry. Bioavailability and Bioequivalence. Studies for Orally Adminsitered Drug Products-General Considerations. 2003.
2. U.S. Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance for Industry. Extended Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations. 1997.
3. U.S. Department of Health and Human Services, Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Guidance for Industry. Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. 2000.
4. National Institute of Health Sciences, Japan. Guideline for Bioequivalence Studies for Generic Products. 22 Dec 1997.
5. Committee for Medicinal Products for Human Use (CHMP). Guideline on the Investigation of Bioequivalence. 20 Jan 2010. London, European Medicines Agency (EMA).
6. Committee for Proprietary Medicinal Products (CPMP). Note for Guidance on Modified Release Oral and Transdermal Dosage Forms. CPMP/EWP/280/96 Corr . 28 Jul 1999. London, The European Agency for the Evaluation of Medicinal Products. 7 May 2011.
7. Health Canada, Therapeutic Products Directorate. Conduct and Analysis of Bioavailability and Bioequivalence Studies-Part A: Oral Dosage Formulations Used for Systemic Effects. 1992.
8. Health Canada, Therapeutic Products Directorate. Conduct and Analysis of Bioavailability and Bioequivalence Studies-Part B: Oral Modified Release Formulations. 1996.
9. Health Canada, Therapeutic Products Directorate. Guidance for Industry. Bioequivalence Requirements: Critical Dose Drugs. 31 May 2006.
10. Health Canada, Therapeutic Products Directorate. Report C. Expert Advisory Committee on Bioavailability, Report on Bioavailability of Oral Dosage formulations, not in Modified Release Form, of Drugs Used for Systemic Effects, having Complicated or Variable Pharmacokinetics. 1992.
11. Medicines Control Council, Department of Health Republic of South Africa. Registration of Medicines: Biostudies. 2003.
12. Committee for Proprietary Medicinal Products. Note for Guidance on the Investigation of Bioavailability and Bioequivalence. EMEA. 26 Jul 2001. London.
13. Efficacy Working Party, EMEA. Questions and Answers on the Bioavailability and Bioequivalence Guideline. CHMP/EWP/40326/2006, 1-5. 21 Jul 2006. London, EMEA.
14. Directive 2001/83/EC of the European Parliament and of the Council of 6 April 2001 on the Community Code Relating to Medicinal Products for Human Use. Official Journal of the European Communities L 311, 67-128. 28 Nov 2004. Available at: http://www.emea.europa.eu/docs/en-GB/document-library/Regulatory- And-procedural-guideline/2009/10/WC500004481.pdf. Accessed 20 Oct 2011.
15. U.S. Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER). Bioequivalence Recommendations for Specific Products. 2010. 22 Jan 2012.
16. Tothfalusi L, Endrenyi L, Arieta AG. Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence. Clin Pharmacokinet. 2009;48(11):725-43.
17. el-Tahtawy AA, Jackson AJ, Ludden TM. Comparison of single and multiple dose pharmacokinetics using clinical bioequivalence data and Monte Carlo simulations. Pharm Res. 1994;11(9):1330-6.
18. Fernandez-Teruel C, Nalda MR, Gonzalez-Alvarez I, Navarro-Fontestad C, Garcia-Arieta A, Casabo VG, Bermejo M. Computer simulations of bioequivalence trials: selection of design and analyte in BCS drugs with first-pass hepatic metabolism: linear kinetics (I). Eur J Pharm Sci. 2009;36 (1):137-46.
19. European Commission Enterprise Directorate-General: Marketing Authorisations; VOLUME 2A Procedures for marketing authorisation. Brussels, 2005. Available at: http://ec.europa.eu/health/files/eudralex/vol-2/a/vol2a- chap1-2005-11-en.pdf. Accessed 20 Oct 2011.
20. Committee for Medicinal Products for Human Use (CHMP). CHMP assessment report. Doxorubicin SUN. European Medicines Agency EMA/588790/2011. 2011. Available at: http://www.ema. europa.eu/docs/en-GB/document-library/Application- withdrawal-Assessment-report/human/002049/WC500112957.pdf. Accessed 24-01-2012
21. European Medicines Agency. Caelyx: EPAR-Procedural steps taken before authorisation. European Medicines Agency. 2005. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Procedural-steps- Taken-before-Authorisation/human/000089/WC500020176.pdf. Accessed 24 Jan 2012.
22. The Co-ordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh). Questions and answers on Generic Applications. Head of Medicines Agencies. 2012. Available at: http://www.hma.eu/210.html. Accessed 24 Jan 2012
23. Endrenyi L, Tothfalusi L. Truncated AUC evaluates effectively the bioequivalence of drugs with long half-lives. Int J Clin Pharmacol Ther. 1997;35(4):142-50.
24. Fernandez-Teruel C, Gonzalez-Alvarez I, Navarro-Fontestad C, Garcia-Arieta A, Bermejo M, Casabo VG. Computer simulations of bioequivalence trials: selection of design and analyte in BCS drugs with first-pass hepatic metabolism: Part II. Non-linear kinetics. Eur J Pharm Sci. 2009;36(1):147-56.
25. Navarro-Fontestad C, Gonzalez-Alvarez I, Fernández-Teruel C, Garcia-Arieta A, Bermejo M, Casabó VG. Computer simulations for bioequivalence trials: Selection of analyte in BCS drugs with first-pass metabolism and two metabolic pathways. Eur J Pharm Sci. 2010;41(5):716-28.
26. CHMP Pharmacokinetics Working Party (PKWP). Questions & Answers: Positions on specific questions addressed to the Pharmacokinetics Working Party. 26 Jan 2011. London, European Medicines Agency. Available at: http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/ 09/WC500002963.pdf. Accessed 25 Jan 2012.
27. Garcia-Arieta A, Abad-Santos F, Rodriguez-Martinez MA, Varas-Polo Y, Novalbos J, Laparidis N, et al. An eutomer/distomer ratio near unity does not justify non-enantiospecific assay methods in bioequivalence studies. Chirality. 2005;17 (8):470-5.
28. Torrado JJ, Blanco M, Farre M, Roset P, Garcia-Arieta A. Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies. Eur J Clin Pharmacol. 2010;66 (6):599-604.
29. Boni JR, Korth-Bradley JM, Richards LS, Chiang ST, Hicks DR, Benet LZ. Chiral bioequivalence: effect of absorption rate on racemic etodolac. Clin Pharmacokinet. 2000;39(6):459-69.
30. Dissanayake S. Assessing the bioequivalence of analogues of endogenous substances ('endogenous drugs'): considerations to optimize study design. Br J Clin Pharmacol. 2010;69(3):238-44.
31. Endrenyi L, Tothfalusi L. Regulatory conditions for the determination of bioequivalence of highly variable drugs. J Pharm Pharm Sci. 2009;12(1):138-49.
32. Commission Regulation (EC) No 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products. Official Journal of the European Union L 334/7. 12 Dec 2008. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/reg-2008-1234/reg-2008-1234-en. pdf. Accessed 20 Oct 2011.
33. Directive 2009/53/EC of the European Parliament and of the Council of 18 June 2009 amending Directive 2001/82/EC and Directive 2001/83/EC, as regards variations to the terms of marketing authorisations for medicinal products. Official Journal of the European Union L 168/33. 30 Jun 2009. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ: L:2009:168:0033:0034: en:PDF. Accessed 20 Oct 2011.
34. van Os S, Relleke M, Piniella PM. Lack of bioequivalence between generic risperidone oral solution and originator risperidone tablets. Int J Clin Pharmacol Ther. 2007;45 (5):293-9.
35. Spanish Experience in Bioequivalence. Biointernational 2008. London, United Kingdom: 2008.
36. Yu LX, Amidon GL, Polli JE, Zhao H, Mehta MU, Conner DP, et al. Biopharmaceutics classification system: the scientific basis for biowaiver extensions. Pharm Res. 2002;19(7):921-5.
37. Benet LZ, Amidon GL, Barends DM, Lennernas H, Polli JE, Shah VP, et al. The use of BDDCS in classifying the permeability of marketed drugs. Pharm Res. 2008;25(3):483-8.
38. Benet LZ, Larregieu CA. The FDA should eliminate the ambiguities in the current BCS biowaiver guidance and make public the drugs for which BCS biowaivers have been granted. Clin Pharmacol Ther. 2010;88(3):405-7.
39. Wu CY, Benet LZ. Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system. Pharm Res. 2005;22(1):11-23.
40. World Health Organization. Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. WHO. WHO Technical Report Series 937. Geneva: WHO Press. WHO Expert Committee on Specifications for Pharmaceutical Preparations; 2006. p. 347-90.