Module 3 - Strategic case studies in practice

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García-Arieta and Gordon

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 deter- mination 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. Of fi cial Journal of the European Union L 334/7. 12 Dec 2008. Available at: http://ec.europa.eu/health/ fi les/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. Of fi cial 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 classi fi cation system: the scienti fi c 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 develop- ment of a biopharmaceutics drug disposition classi fi cation system. Pharm Res. 2005;22(1):11 – 23. 40. World Health Organization. Multisource (generic) pharmaceuti- cal products: guidelines on registration requirements to establish interchangeability. WHO. WHO Technical Report Series 937. Geneva: WHO Press. WHO Expert Committee on Speci fi cations for Pharmaceutical Preparations; 2006. p. 347 – 90.