Bioequivalence: Issues and perspectives

Indian Journal of Pharmacology

Volumn 39, Issue 5, 2007, Pages 218-225

  Rani, Shubha ^a  

^a Synchron Research Services Pvt Ltd   (India)

Author keywords

Bioequivalence; Current thinking on bioequivalence studies; Issues in bioequivalence

Indexed keywords

ANALGESIC AGENT; ANTACID AGENT; ANTIARRHYTHMIC AGENT; ANTIBIOTIC AGENT; ANTIHISTAMINIC AGENT; ANTITHYROID AGENT; CARBAMAZEPINE; DIGOXIN; DIMERCAPROL; LEVOTHYROXINE; THEOPHYLLINE; VITAMIN;

AREA UNDER THE CURVE; AWARENESS; BIOAVAILABILITY; BIOEQUIVALENCE; DRUG FORMULATION; DRUG HALF LIFE; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GENETIC POLYMORPHISM; HEALTH CARE; HUMAN; PACKAGING; PRACTICE GUIDELINE; REVIEW; VOLUNTEER;

EID: 36849091066     PISSN: 02537613     EISSN: None     Source Type: Journal    
DOI: 10.4103/0253-7613.37271     Document Type: Review

References (92)

1. Food and Drug Administration (FDA), the Division of Bioequivalence, Office of Generic Drugs. Guidance on statistical procedures for bioequivalence studies using a standard two-treatment crossover design, 2001. Available from: http://www.fda.gov/cder/guidance/index.htm.
2. Canadian Health Protection Branch (HPB), Drugs Directorate Policy: CI standard for comparative bioavailability, 1991.
3. Committee for Proprietary Medicinal Products (CPMP), Working Party on Efficacy of Medicinal Products. Note for guidance: Investigation of bioavailability and bioequivalence (CPMP/EWP/QWP/1401/98 draft), 1991.
4. Division of Bioequivalence, Generic Drug Advisory Committee Meeting, Washington D.C; September 26-27, 1992.
5. Food and Drug Administration (FDA), Centre for Drug Evaluation and Research. Guidance for Industry: Bioavailability and bioequivalence for orally administered drug products. General Considerations, 2003. Available from: http://www.fda.gov/cder/guidance/index.htm.
6. Schuirmann DJ. Treatment of BE data: Logarithmic transformation. In: Proceedings of Bio International. 89. Issues in the evaluation of bioavailability data. Toronto, Ontario, Canada; October 1 - 6, 1989. p. 159-61.
7. McGilveray IJ, Midha KK, Skelly JP, Dighe SV, Doluisio JT, French IW, et al. Consensus Report from "Bio International?89": Issues in the evaluation of bioavailability data. J Pharm Sci 1990;79:945-6.
8. Commission of the European Communities, Committee for Proprietary Medicinal Products (CPMP), Working Party on Efficacy of Medicinal Products. Note for Guidance: Investigation of Bioavailability And Bioequivalence, 1991.
9. Health Protection Branch, Health and Welfare Canada. Drug Directorate Guideline: Conduct and Analysis of Bioavailability and Bioequivalence Studies. Part A: Oral Dosage Formulations Used for Systemic Effects (Cat. #H42-2/56-1992), 1992.
10. Expert Advisory Committee on Bioavailability, Health Protection Branch, Health and Welfare Canada. Report C: Bioavailability of oral dosage formulations, not in modified release form, of drugs used for systemic effects, having complicated or variable pharmacokinetics, 1992. Available from: http://www.hc-sc.gc.ca/dhpmps/alt_formats/hpfb-dgpsa/pdf/prodpharma/ biorepc_biorapc_e.pdf.
11. Rani S, Pargal A. Bioequivalence: An overview of statistical concepts. Indian J Pharmacol 2004;36:209-16.
12. McGilveray IJ. An overview of problems and progress at Bio-Internationals ?89 and ?92. In: Biointernational 2 Bioavailability, Bioequivalence and Pharmacokinetic Studies. Blume HH, Midha KK, Stuttgart, editors. Medpharm Scientidic Publishers: Germany; 1995. p. 109-15.
13. Buice RG, Subramanian VS, Duchin KL, Uko-Nne S. Bioequivalence of a highly variable drug: An experience with nadolol. Pharm Res 1996;13:1109-15.
14. Tsang YC, Pop R, Gordon P, Hems J, Spino M. High variability in drug pharmacokinetics complicates determination of bioequivalence: Experience with verapamil. Pharm Res 1996;13:846-50.
15. Blume HH, Elze M, Pottha ST, Schug BS. Practical strategies and design advantages in highly variable drug studies: Multiple dose and replicate administration design. In: Biointernational 2 Bioavailability, Bioequivalence and Pharmacokinetic Studies. Blume HH, Midha KK, Stuttgart, editors. Medpharm Scientific Publishers: Germany; 1995. p. 117-22.
16. Midha KK, Rawson MJ, Hubbard JW. Prescribability and switchability of highly variable drugs and drug products. J Control Release 1999;62:33-40.
17. Midha KK, Rawson MJ, Hubbard JW. The bioequivalence of highly variable drugs and drug products. Int J Clin Pharmacol Ther 2005;43:485-98.
18. Midha KK, Rawson MJ, Hubbard JW. Bioequivalence: Switchability and scaling. Eur J Pharm Sci 1998;6:87-91.
19. Jackson AJ. Evaluation of a limited sampling method to determine the bioequivalence of highly variable drugs with long half-lives. Biopharm Drug Dispos 2001;22:179-90.
20. Jackson AJ. The role of metabolites in bioequivalency assessment, III: Highly variable drugs with linear kinetics and first-pass effect. Pharm Res 2000;17:1432-6.
21. Anderson S, Hauck WW. Consideration of individual bioequivalence. J Pharmacokinet Biopharm 1990;18:259-73.
22. Sheiner LB. Bioequivalence revisited. Stat Med 1992;11:1777-88.
23. Chen ML. Individual bioequivalence: A regulatory update. J Biopharm Stat 1997;7:5-11.
24. Endrenyi L. A method for the evaluation of individual bioequivalence. Int J Clin Pharmacol Ther 1994;32:497-508.
25. Anderson S. Individual bioequivalence: A problem of switchability (with discussion). Biopharm Rep 1993;2:1-11.
26. Schall R. A unidied view of individual, population and average bioequivalence. In: Bio-International 2: Bioavailability, Bioequivalence and Pharmacokinetic Studies. Blume HH, Midha KK, editors. Medpharm: Stuttgart; 1995. p. 91-106.
27. Endrenyi L, Schulz M. Individual variation and the acceptance of average bioequivalence. Drug Inform J 1993;27:195-201.
28. th Annual Symposium on Beyond Bioequivalence! Canadian and International Issues in Biopharmaceutics and Pharmacokinetics, June 14 - 16, 2001 Ottawa, Ontario, Canada. JPPS 2001;4:77-137. Available from: http://www.ualberta.ca/~csps/JPPS4(2)/proceedings2001.pdf.
29. Esinhart JD, Chinchilli VM. Extension to the use of tolerance intervals for the assessment of individual bioequivalemce. J Biopharm Stat 1994;4:39-52.
30. Bois FY, Tozer TN, Hauck WW, Chen ML, Patnaik R, Williams RL. Bioequivalence: Performance of several measures of extent of absorption. Pharm Res 1994;11:715-22.
31. Bois FY, Tozer TN, Hauck WW, Chen ML, Patnaik R, Williams RL. Bioequivalence: Performance of several measures of rate of absorption. Pharm Res 1994;11:966-74.
32. Schall R, Luus HG, Steinijans VW, Hauschke D. Choice of characteristics and their bioequivalence ranges for the comparison of absorption rates of immediate release drug formulations. Int J Clin Pharmacol Ther 1994;32:323-8.
33. Macheras P, Symillides M, Reppas C. An improved intercept method for the assessment of absorption rates in bioequivalence studies. Pharm Res 1996;13:1755-8.
34. Tozer TN, Bois FY. Metrics of absorption: Simulation approach. In: Bio-International: Bioavailability, Bioequivalence and Pharmacokinetic studies. Blume HH, Midha KK, editors. 1994.
35. Duquesnoy C, Lacey LF, Keene ON, Bye A. Evaluation of different partial AUCs as indirect measures of rate of drug absorption in comparative pharmacokinetic studies. Eur J Pharm Sci 1998;6:259-64.
36. Endrenyi L, Csizmadia F, Tothfalusi L, Chen ML. Metrics comparing simulated early concentration profiles for the determination of bioequivalence. Pharm Res 1998;15:1292-9.
37. Tozer TN, Bois FY, Hauck WW, Chen ML, Williams RL. Absorption rate vs. exposure: Which is more useful for bioequivalence testing. Pharm Res 1996;13:453-6.
38. 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;15:1621-9.
39. max with different dissolution rates. Pharm Res 1999;16:939-43.
40. Endrenyi L, Tothfalusi L, Lalonde RL, Gaudreault J. Partial AUC is effective for assessing the bioequivalence of drugs with long half-lives. Clin Pharmacol Ther 1996;59:152.
41. 0-72 in bioequivalence assessment for drugs with a long half-life. Pharm Res 1996;13:S477.
42. Endrenyi L, Tothfalusi L. Truncated AUC evaluates effectively the bioequivalence of drugs with long half-lives. Int J Clin Pharmacol Ther 1997;35:142-50.
43. Marzo A, Ceppi Monti N, Vuksic D. Experimental, extrapolated and truncated areas under the concentration-time curve in bioequivalence trials. Eur J Clin Pharmacol 1999;55:627-31.
44. Mahmood I, Mahayni H. A limited sampling approach in bioequivalence studies: Application to long half life drugs and replicate design studies. Int J Clin Pharmacol Ther 1999;37:275-81.
45. Palylyk-Colwell E, Jamali F, Dryden W, Friesen E, Koven S, Mohamed I, et al. Bioequivalence and interchangeability of narrow therapeutic range drugs: Canadian Society for pharmaceutical sciences discussion. J Pharm Pharm Sci 1998;1:2-7.
46. Meredith PA. Generic drugs: Therapeutic equivalence. Drug Saf 1996;15:233-42.
47. Food and Drug Administration. Code of Federal Regulations. Title 21, Part 320: Bioavailability and Bioequivalence Requirements. Section 320.33(c). 2003. Available from: http://www.accessdata.fda.gov.
48. Average, Population and Individual Approaches to Establishing Bioequivalence. 1999 FDA/CDER Web site. Available from: http://www.fda.gov/cder/ guidance/1716dft.pdf.
49. Reiffel JA. Issues in the use of generic antiarrhythmic drugs. Curr Opin Cardiol 2001;16:23-9.
50. Grubb BP. Recurrence of ventricular tachycardia after conversion from proprietary to generic procainamide. Am J Cardiol 1989;63:1532-3.
51. Ozahowski TP, Greenberg MI, Mock RP. Clinical in equivalence of generic and brand name type IA antiarrhyl. Pacing Clin Electrophysiol 1998;21:809.
52. Reiffel JA, Kowey PR. Generic antiarrhythmics are not therapeutically equivalent for the treatment of tachyarrhythmias. Am J Cardiol 2000;85:1151-3.
53. Kowey PR. Pharmacological effects of antiarrhythmic drugs: Review and update. Arch Intern Med 1998;158:325-32.
54. Kowey PR. What to do about prescribing generic antiarrhythmic drugs. Clin Dialogues on Arrhythmias 1990;2:1-3.
55. American Thyroid Association, The Endocrine Society and ThyCa. Public Health Statement on Continued Availability of Thyroid Hormone Products. 2001. Available from: http://www.thyroid.org/professionals/publications/ statements/01_06_04_hormone.html.
56. Singer PA, et al. Public Heath Statement on Levothyroxine. 2003. Available from: http://www.thyroid.org/professionals/publications/statements/ 03_04_04_levo.htm.
57. European Medicines Agency, 27 July 2006, EMEA/CHMP/EWP/40326/2006.
58. Marzo A, Rescigno A. Pharmacokinetics of endogenous substances: Some problems and some solutions. Eur J Drug Metab Pharmacokin 1993;18:77-88.
59. Marzo A. Open questions in bioequivalence. Pharm Res 1995;32:237-40.
60. Evans WE, Relling MV. Pharmacogenomics: Translating functional genomics into rational therapeutics. Science 1999;286:487-91.
61. Marzo A, Balant LP. Investigation of xenobiotic metabolism by CYP2D6 and CYP2C19: Importance of enentioselective analytical methods. J Chromatogr B Biomed Appl 1996;678:73-92.
62. Patnaik R, Lesko LJ, Chan K, Williams RL. Bioequivalence assessment of generic drugs: An American point of view. Eur J Drug Metab Pharmacokinet 1996;21:159-64.
63. Welage LS, Kirking DM, Ascione FJ, Gaither CA. Understanding the scientific issues embedded in the generic drug approval process. J Am Pharm Assoc (Wash) 2001;41:856-67.
64. Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 2003;25:11.
65. Marzo A, Balant LP. Bioequivalence: An updated reappraisal addressed to application of interchangeable multi-source pharmaceutical products. Arzneimittelforschung 1995;45:109-15.
66. Nation RL, Sansom LN. Bioequivalence requirements for generic products. Pharmacol Ther 1994;62:41-55.
67. Besag FM. Is generic prescribing acceptable in epilepsy? Drug Saf 2000;23:173-82.
68. Elkoshi Z, Behr D, Mirimsky A. Multiple-dose studies can be a more sensitive assessment for bioequivalence than single-dose studies: The case with omeprazole. Clin Drug Invest 2002;22:585-92.
69. Chen ML, Jackson AJ. The role of metabolites in bioequivalency assessment: I: Linear pharmacokinetics without first-pass effect. Pharm Res 1991;8:25-32.
70. Jackson A, Robbie G, Marroum P. Metabolites and bioequivalence past and present. Clin Pharmacokinet 2004;43:655-72.
71. Blume HH, Midha KK. Report of consensus meeting: Bio-International 94, conference on bioavailability, bioequivalence and pharmacokinetic studies. Eur J Pharm Sci 1995;3:113-24.
72. Committee for Proprietary Medicinal Products (CPMP), Note For Guidance: Investigation Of Bioavailability And Bioequivalence (CPMP/EWP/QWP/1401/98), 2001. Available from: http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf.
73. Datz FL, Christian PE, Moore J. Gender-related differences in gastric emptying. J Nucl Med 1987;28:1204-7.
74. Yonkers KA, Kando JC, Cole JO, Blumenthal S. Gender differences in pharmacokinetics and pharmacodynamics of psychotropic medication. Am J Psychiatry 1992;149:587-95.
75. Harris RZ, Benet LZ, Schwartz JB. Gender effects in pharmacokinetics and pharmacodynamics. Drugs 1995;50:222-39.
76. Lindahl A, Ungell AL, Knutson L, Lennernas H. Characterization of fluids from the stomach and proximal jejunum in men and women. Pharma Res 1997;14:497-502.
77. Chen ML, Lee SC, Ng MJ, Schuirmann DJ, Lesko LJ, Williams RL. Pharmacokinetic analysis of bioequivalence trials: Implications for sex-related issues in clinical pharmacology and biopharmaceutics. Clin Pharm Ther 2000;68:510-21.
78. U.S. Food and Drug Administration. Guideline for the study and evaluation of gender differences in clinical evaluation of drugs. Fed Regist 1993;58:39406-16.
79. Webster C, Copmann T, Garnick R, Green J, Hayes M, Landis J, et al. Biologics: Can there be abbreviated applications, generics or follow on products? BioPharm Int 2003.
80. Rader RA. What is a generic biopharmaceutical? Biogeneric? Follow-on protein? Biosimilar? Follow-on biologic? Part 1: Introduction and basic paradigms. BioProcess Int 2007;5:28-38.
81. Casadevall N, Nataf J, Viron B, Kolta A, Kiladjian JJ, Martin-Dupont P, et al. Pure red-cell aplasa and antierythropoietin antibodies in patients treated with recombinant erythropoietin. N Engl J Med 2002;346:469-75.
82. Schellekens H. Bioequivalence and the immunogenecity of biopharmaceuticals. Nat Rev Drug Discov 2002;1:457-62.
83. Casadevall N, Eckardt KU, Rossert J. Epoetin-induced autoimmune pure red-cell aplasia. J Am Soc Nephrol 2005;16:S67-9.
84. Combe C, Tredree RL, Schellekens H. Biosimilar epoetins: An analysis based on recently implemented European medicines evaluation agency guidelines on comparability of biopharmaceutical proteins. Pharmacotherapy 2005;25:954-62.
85. Stavchansky S. Pharmaceutical equivalence of biologic drug products. J Pharm Pharm Sci 2001;4:77-137.
86. Teare I. Biosimilar warfare: The arrival of generic biopharmaceuticals- the omnitrope decision. Bio-science Law Rev 2005;8:9-13. Available from: http://www.lawtext.com.
87. Committee for Medicinal Products for Human (CHMP), Guideline on Similar Biological Medicinal Products (CHMP/437/04), 2005. Available from: http://www.emea.europa.eu/pdfs/human/biosimilar/043704en.pdf.
88. Committee for Medicinal Products for Human (CHMP), Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins As Active Substance: Non-Clinical And Clinical Issues (EMEA/CHMP/ BMWP/42832/2005), 2006. Available from: http://www.emea.europa.eu/pdfs/human/biosimilar/ 4283205en.pdf.
89. Committee for Medicinal Products for Human (CHMP), Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins As Active Substance: Non-Clinical And Clinical Issues (EMEA/CHMP/ BMWP/31329/2005), 2006. Available from: http://www.emea.europa.eu/pdfs/human/biosimilar/ 3132905en.pdf.
90. Committee for Medicinal Products for Human (CHMP), Annex to Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues, Guidance on Similar Medicinal Products Containing Recombinant Human Soluble Insulin (EMEA/CHMP/BMWP/32775/2005), 2006. Available from: http://www.emea.europa.eu/ pdfs/human/biosimilar/3277505en.pd.
91. Diede ML, Liliedahl R. Health care cost control. Getting on the right track. Manag Care 2002;11:24-5,29-33.
92. Countering delays in introduction of generic drugs. Lancet 2002;359:181.