Evaluation of bioequivalence of highly variable drugs

Clinical Research and Regulatory Affairs

Volumn 25, Issue 2, 2008, Pages 93-117

  Endrenyi, Laszlo ^a   Tothfalusi, Laszlo ^b  

^a UNIVERSITY OF TORONTO   (Canada)

^b SEMMELWEIS UNIVERSITY   (Hungary)

Author keywords

[No Author keywords available]

Indexed keywords

LORATADINE; NADOLOL; PROPAFENONE; VERAPAMIL;

BIOEQUIVALENCE; CANADA; DRUG ABSORPTION; DRUG ACCUMULATION; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG FORMULATION; DRUG HALF LIFE; FOOD AND DRUG ADMINISTRATION; REVIEW;

EID: 45949084855     PISSN: 10601333     EISSN: 15322521     Source Type: Journal    
DOI: 10.1080/10601330802131451     Document Type: Review

References (69)

1. Blume HH, Midha KK. Bio-International 92, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies. J Pharm Sci. 1993. 11:1186-1189.
2. Blume HH, McGilveray IJ, Midha KK. Bio-International 94, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies. Eur J Pharm Sci. 1995; 3:113-124.
3. Midha KK, Nagai T, Blume HH, et al. Conference Report: Bio-International '96, Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies, Tokyo, Japan; April 22-24, 1996. In: Midha KK, Nagai T, eds. Bioavailability, Bioequivalence and Pharmacokinetic Studies. Tokyo: Academic Societies Japan; 1996:1-8.
4. Shah VP, Yacobi A, Barr WH, et al. Evaluation of orally administered drugs and drug formulations. Pharm Res. 1996;13:1590-1594.
5. American Association of Pharmaceutical Sciences, Symposium on "Bioequivalence of Highly Variable Drugs and Drug Products." Nashville, TN; Nov 9, 2005.
6. Schuirmann D. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokin Biopharm. 1987;15:657-680.
7. Benet L. Bioavailability and bioequivalence: definitions and difficulties in acceptance criteria. In: Midha KK, Blume HH, eds. Bio-International, Bioavailability, Bioequivalence and Pharmacokinetics. Stuttgart: Medpharm; 1993:27-35.
8. Benet L. Individual bioequivalence: an overview. AAPS International Workshop on Individual Bioequivalence: Realities and Implementation. Montreal, Quebec; Aug 30-Sep 1, 1999.
9. Ducharme MP, Potvin D. Understanding bioequivalence-the experience of a global contract research organization. Business Briefing: Pharmagenerics. 2003:53-60.
10. Tsang YC, Pop R, Gordon P, et al. High variability in drug pharmacokinetics complicates determination of bioequivalence: experience with verapamil. Pharm Res. 1993;13:846-850.
11. Midha KK, Rawson MJ, Hubbard JW. The bioequivalence of highly variable drugs and drug products. Int J Clin Pharmacol Ther. 2005:43:485-98.
12. Health Canada. Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A: Oral Dosage Formulations Used for Systemic Effects. Ottawa: Health Protection Branch, Drugs Directorate; 1992:1-80.
13. CPMP. Note for Guidance on the Investigation of Bioavailability and Bioequivalence. London: European Agency for the Evaluation of Medicinal Products (EMEA), Committee for Proprietary Medicinal Products; 2001:1-22.
14. Blume HH, Elze M, Potthast H, Schug BS. Practical strategies and design advantages in highly variable drug studies: multiple dose and replicate administration design. In: Blume HH, Midha KK, eds. Bio-International 2, Bioavailability, Bioequivalence and Pharmacokinetics. Stuttgart: Medp-harm; 1995:117-122.
15. Schug BS, Elze M, Blume HH. Bioequivalence of highly variable drugs and drug products: steady state studies. In: Midha KK, Nagai T, eds. Bioavailability, Bioequivalence and Pharmacokinetic Studies. Tokyo: Academic Societies Japan; 1996:101-106.
16. 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;11:1330-1336.
17. El-Tahtawy AA, Jackson AJ, Ludden TM. Evaluation of bioequivalence of highly variable drugs using Monte Carlo simulations. Part 1. Estimation of rate of absorption for single and multiple dose trials using Cmax. Pharm Res. 1995;12:1634-1641.
18. Zha J, Endrenyi L. Variation of the peak concentration following single and repeated drug administrations in investigations of bioavailability and bioequivalence. J Biopharm Stat. 1997;7:191-204.
19. Zha J, Tothfalusi L, Endrenyi L. Properties of metrics applied for the evaluation of bioequivalence. Drug Information J. 1995;29:989-996.
20. FDA. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products - General Considerations, Guidance for Industry. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2003:1-46.
21. El-Tahtawy AA, Tozer TN, Harrison F, et al. Evaluation of bioequivalence of highly variable drugs using clinical trial simulations. II: Comparison of single and multiple-dose trials using AUC and Cmax. Pharm Res. 1998;15:98-104.
22. Tothfalusi L, Endrenyi L. Estimation of Cmax and Tmax in populations after single and multiple drug administrations. J Pharmacokin Pharmacodyn. 2003;30:363-385.
23. Anderson S, Hauck WW. Consideration of individual bioequivalence. J Pharmacokin Biopharm. 1990;18:259-273.
24. Sheiner LB. Bioequivalence revisited. Stat Med. 1992;11:1777-1788.
25. Schall R, Williams RL. Towards a practical strategy for assessing individual bioequivalence. J Pharmacokin Biopharm. 1996;24:133-149.
26. Schall R, Luus HE. On population and individual bioequivalence. Stat Med. 1993;12:1109-1124.
27. Patnaik RN, Lesko LJ, Chen ML, Williams RL. Individual bioequivalence: new concepts in the statististical assessment of bioequivalence metrics. Clin Pharmacokin. 1997;33:1-6.
28. FDA. Statistical Approaches to Establishing Bioequivalence, Guidance for Industry. Rockville, MD: Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2001:1-48.
29. Boddy AW, Snikeris FC, Kringle RO, Wei GCG, Opperman JA, Midha KK. An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs. Pharm Res. 1995;12:1865-1868.
30. Schall R. A unified view of individual, population, and average bioequivalence. In: Blume HH, Midha KK, eds. Bio-International 2, Bioavailability, Bioequivalence and Pharmacokinetics. Stuttgart: Medpharm; 1995:91-106.
31. Tothfalusi L, Endrenyi L, Midha KK, Rawson MJ, Hubbard JW. Evaluation of the bioequivalence of highly-variable drugs and drug products. Pharm Res. 2001;18:728-733.
32. Chen ML. Individual bioequivalence - a regulatory update (with discussion). J Biopharm Stat. 1997;7:5-11.
33. http://www.fda.gov/ohrms/dockets/ac/04/slides/4034s2.htm
34. Medicines Control Council of South Africa. Biostudies. Pretoria, South Africa; 2003:1-18.
35. Kanfer I, Skinner MF, Walker RB. Guidelines for bioavailability and bioequivalence: an innovative South African approach. London: BioInternational; 2003.
36. EMEA. Concept Paper for an Addendum to the Note for Guidance on the Investigation of Bioavailability and Bioequivalence: Evaluation of Bioequivalence of Highly Variable Drugs and Drug Products; April 27, 2006.
37. Schall R. Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar. Biometrics. 1995;51:615-26.
38. Wellek S. On a reasonable disaggregate criterion of population bioequivalence admitting of resampling-free testing procedures. Stat Med. 2000;19:2755-2767.
39. Steinijans VW. Some conceptual issues in the evaluation of average, population, and individual bioequivalence. Drug Information J. 2001;35:893-899.
40. Wellek S. Testing Statistical Hypotheses of Equivalence. Boca Raton, London: Chapman & Hall/CRC; 2003.
41. Chow S-C, Liu J-P. Design and Analysis of Bioavailability and Bioequivalence Studies. 2nd ed. New York, Basel: Marcel Dekker; 2000.
42. Patterson S, Jones B. Bioequivalence and Statistics in Clinical Pharmacology. Boca Raton, London: Chapman & Hall/CRC; 2006.
43. Tothfalusi L, Endrenyi L. Limits for the scaled average bioequivalence of highly variable drugs and drug products. Pharm Res. 2003;20:382-389.
44. Midha KK, Rawson M, Hubbard JW, Ormsby ED. Practical strategies and design advantages for highly variable drugs: replicate design. In: Blume HH, Midha KK, eds. Bio-International 2, Bioavailability, Bioequivalence and Pharmacokinetics. Stuttgart: Medpharm; 1995:123-128.
45. Chow, S-C. Statistical considerations for replicated designs. In: Midha KK, Nagai T, eds. Bioavailability, Bioequivalence and Pharmacokinetic Studies. Tokyo: Academic Societies Japan; 1996:107-112.
46. Endrenyi L, Taback N, Tothfalusi L. Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence. Stat Med. 2000;19:2867-2878.
47. Gould AL. A practical approach for evaluating population and individual bioequivalence. Stat Med. 2000;19:2721-2740.
48. Guilbaud O. Exact inference about the within-subject variance in 2 x 2 cross-over studies. J Amer Stat Assoc. 1993;88:939-946.
49. Guilbaud O. Exact comparisons of means and variances in 2 x 2 cross-over trials. Drug Info J. 1999;33:455-469.
50. Endrenyi L, Tothfalusi L. Truncated AUC evaluates effectively the bioequivalence of drugs with long half-lives. Int J Clin Pharmacol Ther. 1997;35:142-150.
51. Gaudreault J, Potvin D, Lavigne J, Lalonde RL. Truncated area under the curve as a measure of relative extent of bioavailability: evaluation using experimental data and Monte Carlo simulations. Pharm Res. 1998;15:1621-1629.
52. Midha KK, Rawson M, Hubbard JW. Individual and average bioequivalence of high variability drugs and drug products. J Pharm Sci. 1997;86:1193-1197.
53. Dragalin V, Fedorov V, Patterson S, Jones B. Kullback-Leibler divergence for evaluating bioequivalence. Stat Med. 2003;22:913-930.
54. Steiger JH. Beyond the F test: Effect size confidence intervals and tests of close fit in the analysis of variance and contrast analysis. Psychol Meth. 2004;9:164-182.
55. Cumming G, Finch S. A primer on the understanding, use, and calculation of confidence intervals that are based on central and noncentral distributions. Educ Psychol Meas. 2001;61:532-574.
56. Chan LK, Cheng SW, Spiring FA. New measure of process capability: Cpm. J Qual Technol. 1989;20:162-175.
57. Feinstein AR. Indexes of contrast and quantitative significance for comparisons of two groups. Stat Med. 1999;18:2557-2581.
58. Cohen J. Statistical Power Analysis for the Behavioral Sciences. New York: Academic Press; 1969.
59. Borenstein M. Hypothesis testing and effect size estimation in clinical trials. Ann Allergy Asthma Immunol. 1997;78:5-11.
60. Hyslop T, Hsuan F, Holder DJ. A small sample confidence interval approach to assess individual bioequivalence. Stat Med. 2000;19:2885-2897.
61. Schuirmann DJ. Average bioequivalence criterion with replicate designs. AAPS International Workshop on Individual Bioequivalence: Realities and Implementation, Montreal, Quebec; Aug 30-Sep 1, 1999.
62. SAS statistical program package. SAS Institute, Inc., Gary, NC.
63. Hsuan FC, Reeve R. Assessing individual bioequivalence with high-order crossover designs: a unified procedure. Stat Med. 2003;22:2847-2860.
64. Vuorinen J, Turunen J. A three-step procedure for assessing bioequivalence in the general mixed-model framework. Stat Med. 1996;15:2635-2655.
65. Vuorinen J, Turunen J. A simple three-step procedure for parametric and nonparametric assessment of bioequivalence. Drug Info J. 1997;31:167-180.
66. Hauck WW, Parekh A, Lesko L, et al. Limits of 80%-125% for AUC and 70-143% for Cmax: What is the impact on bioequivalence studies? Int J Clin Pharmacol Ther. 2001;39:350-355.
67. Tothfalusi L, Endrenyi L, Midha KK. Scaling or wider bioequivalence limits for highly variable drugs and for the special case of Cmax. Int J Clin Pharmacol Ther. 2003;41:217-225.
68. Karalis V, Symillides M, Macheras P. Novel scaled average bioequivalence limits based on GMR and variability considerations. Pharm Res. 2004;21:1933-1942.
69. Karalis V, Macheras P, Symillides M. Geometric mean ratio-dependent scaled bioequivalence limits with leveling-off properties. Eur J Pharm Sci. 2005;26:54-61.