Regulatory conditions for the determination of bioequivalence of highly variable drugs

Journal of Pharmacy and Pharmaceutical Sciences

Volumn 12, Issue 1, 2009, Pages 138-149

  Endrenyi, Laszlo ^a   Tothfalusi, Laszlo ^b  

^a UNIVERSITY OF TORONTO   (Canada)

^b SEMMELWEIS UNIVERSITY OF MEDICINE   (Hungary)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG; HIGHLY VARIABLE DRUG; UNCLASSIFIED DRUG;

ARTICLE; BIOEQUIVALENCE; CONSUMER; CONTROLLED STUDY; CRITERION VARIABLE; DRUG FORMULATION; ESTIMATED RATIO OF GEOMETRIC MEANS; FOOD AND DRUG ADMINISTRATION; INTERMETHOD COMPARISON; MATHEMATICAL ANALYSIS; RISK ASSESSMENT; SCALED AVERAGE BIOEQUIVALENCE; STANDARDIZATION; UNCERTAINTY; ALGORITHM; AREA UNDER THE CURVE; CHEMISTRY; METHODOLOGY; PHARMACEUTICS; PHARMACOKINETICS; REFERENCE VALUE; STANDARD; STATISTICAL MODEL;

ALGORITHMS; AREA UNDER CURVE; CHEMISTRY, PHARMACEUTICAL; MODELS, STATISTICAL; PHARMACEUTICAL PREPARATIONS; PHARMACOKINETICS; REFERENCE STANDARDS; REFERENCE VALUES; TECHNOLOGY, PHARMACEUTICAL; THERAPEUTIC EQUIVALENCY;

EID: 70349316406     PISSN: None     EISSN: 14821826     Source Type: Journal    
DOI: 10.18433/j3zw2c     Document Type: Article

References (29)

1. L. Benet. Bioavailability and bioequivalence: definitions and difficulties inacceptance criteria. In K.K. Midha and H.H. Blume (eds.), Bio-International: Bioavailability, Bioequivalence and Pharmacokinetics, Medpharm, Stuttgart, 1995, pp. 27-35.
2. K.K. Midha, M.J. Rawson, and J.W. Hubbard. The bioequivalence of highly variable drugs and drug products. Int. J. Clin. Pharmacol. Ther. 43: 485-498 (2005).
3. L. Benet. Individual bioequivalence: an overview. AAPS International Workshop on Individual Bioequivalence: Realities and Implementation, Montreal, Quebec, Aug 30-Sep 1, 1999.
4. H.H. Blume and K.K. Midha. Bio-International 92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies. J. Pharm. Sci. 11: 1186-1189 (1993).
5. H.H. Blume, I.J. McGilveray, and K.K. Midha. Bio-International 94, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies. Eur. J. Pharm. Sci. 3: 113-124 (1995).
6. V.P. Shah, A. Yacobi, W.H. Barr, D. Breimer, M.R. Dobrinska, L. Endrenyi, W. Fairweather, W. Gillespie, M.A. Gonzalez, J. Hooper, A. Jackson, L.J. Lesko, K.K. Midha, P.K. Noonan, R. Patnaik, and R.L. Williams. Evaluation of orally administered drugs and drug formulations. Pharm. Res. 13: 1590-1594 (1996).
7. K.K. Midha, T. Nagai, H.H. Blume, J.W. Hubbard, I.J. McGilveray, and R.L. Williams. Conference Report: Bio-International '96, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies, Tokyo, Japan, April 22-24, 1996. In K.K. Midha and T. Nagai (eds.), Bioavailability, Bioequivalence and Pharmacokinetic Studies, Academic Societies Japan, Tokyo, 1996, pp. 1-8.
8. K.K. Midha, V.P. Shah, G.J.P. Singh, and R. Patnaik. Conference report: Bio-International 2005. J. Pharm. Sci. 96: 747-754 (2007).
9. A.W. Boddy, F.C. Snikeris, R.O. Kringle, G.C.G. Wei, J.A. Opperman, and K.K. Midha. An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs. Pharm. Res. 12: 1865-1868 (1995).
10. L. Tothfalusi, L. Endrenyi, K.K. Midha, M.J. Rawson, and J.W. Hubbard. Evaluation of the bioequivalence of highly-variable drugs and drug products. Pharm. Res. 18: 728-733 (2001).
11. BEBAC reviews. Highly variable drugs, EUEMEA. http://bebac.at/news/2006-04-27.htm (accessed 11/17/2008).
12. S.H. Haidar, B. Davit, M.-L. Chen, D. Conner, L.M. Lee, Q.H. Li, R. Lionberger, F. Makhlouf, D. Patel, D.J. Schuirmann, and L.X. Yu. Bioequivalence approaches for highly variable drugs and drug products. Pharm. Res.15: 237-241 (2008).
13. S.H. Haidar, F. Makhlouf, D.J. Schuirmann, T. Hyslop, B. Davit, D. Conner, and L.X. Yu. Evaluation of a scaling approach for the bioequivalence of highly variable drugs. AAPS J. 10: 450-454 (2008).
14. D. Schuirmann. A comparison of the two onesided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokin. Biopharm. 15: 657-680 (1987).
15. L. Tothfalusi, and L. Endrenyi. Limits for the scaled average bioequivalence of highly variable drugs and drug products. Pharm. Res. 20: 382-389 (2003).
16. L.X. Yu. Bioequivalence of highly variable drugs. Meeting of FDA Committee for Pharmaceutical Science, October 6, 2006. http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_1.htm (accessed 11/17/2008).
17. S.H. Haidar. Evaluation of the scaling approach for highly variable drugs. Meeting of FDA Committee for Pharmaceutical Science, October 6, 2006. http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_4.htm (accessed 11/17/2008).
18. B.M. Davit. Highly variable drugs-bioequivalence issues: FDA proposal under consideration. Meeting of FDA Committee for Pharmaceutical Science, October 6, 2006. http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_5.htm (accessed 11/17/2008).
19. S.H. Haidar. BE for highly variable drugs-FDA perspective. AAPS/FDA Workshop on BE, BCS, and Beyond, North Bethesda, MD, May 22, 2007. http://www.aapspharmaceutica.com/meetings/files/90/22Haidar.pdf (accessed 11/17/2008).
20. B.M. Davit. Highly variable drugs-bioequivalence issues: FDA proposal under consideration. AAPS/FDA Workshop on BE, BCS, and Beyond, North Bethesda, MD, May 22, 2007.
21. T. Hyslop, F. Hsuan, and D.J. Holder. A small sample confidence interval approach to assess individual bioequivalence. Stat. Med. 19: 2885-2897 (2000).
22. D. Hauschke, V. Steinijans, and I. Pigeot. Bioequivalence Studies in Drug Development. Wiley, Chichester, 2007, pp. 44-46.
23. L. Endrenyi and L. Tothfalusi. Evaluation of bioequivalence of highly variable drugs. In I. Kanfer and L. Shargel (eds.), Generic Drug Product Development-Bioequivalence Issues, Informa, New York, London, 2008, pp. 97-121.
24. L. Benet. Why highly variable drugs are safer. Meeting of FDA Committee for Pharmaceutical Science, October 6, 2006. http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_2.htm (accessed 11/17/2008).
25. max. Int. J. Clin. Pharmacol. Ther. 41: 217-225 (2003).
26. Health Canada. Guidance for Industry. Conduct and Analysis of Bioavailability and Bioequivalence Studies. Part A: Oral Dosage Formulatios Used for Systemic Effects. Health Canada, Ottawa, 1992.
27. V. Karalis, M. Symillides, and P. Macheras. Novel scaled average bioequivalence limits based on GMR and variability considerations. Pharm. Res. 21: 1933-1942 (2004).
28. V. Karalis, P. Macheras, and M. Symillides. Geometric mean ratio-dependent scaled bioequivalence limits with leveling-off properties. Eur. J. Pharm. Sci. 26: 54-61 (2005).
29. J. Kytariolos, V. Karalis, P. Macheras, and M. Symillides. Novel scaled bioequivalence limits with leveling-off properties. Pharm. Res. 23: 2657-2664 (2006).