Main Article Content
Abstract
The present study was aimed to study the requirements of bioequivalence for the registration of pharmaceutical products. Before going into bioequivalence studies it is essential for the pharmaceutical industry to study the guidelines of bioequivalence for the respective country where the industry wants to market its products and thus enter into generic market. This study reviews the requirements of bioequivalence with study parameters such as study design, fasting or fed state studies, volunteers recruitment, study dose, sampling points, analytical method validation parameters, moieties to be measured in plasma, pharmacokinetic parameters, criteria for bioequivalence, which are needed for the pharmaceutical industry to carry out bioequivalence studies and to file ANDA. Test products and reference products are needed for this study. Test products are usually manufactured by a sponsor and reference products are provided by the government laboratories of the respective countries. Sampling points also vary with respect to the regulatory guidelines of a country.
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References
- 1. Banahan, B. F. & Kolassa, E. M. (1997). A physician survey on generic drugs and substitution of critical dose medications, Archive of Internal Medicine, 157, 2080-2088.
- 2. Benet, L. Z. & Goyan, J. E. (1995). Bioequivalence and narrow therapeutic index drugs, Pharmacotherapy, 15, 433-440.
- 3. Boix-Montanes A. (2011). Relevance of equivalence assessment of topical products based on the dermatopharmacokinetics approach, European Journal of Pharmaceutical Sciences, 42 (3), 173-9.
- 4. Central Drugs Standard Control Organization (CDSCO) (2005). Guidelines for bioavailability and bioequivalence studies. Directorate General of Health Services.
- 5. Ministry of Health and Family Welfare, Government of India, New Delhi. Available from: http://cdsco.nic.in/html/BE%20Guidelines%20Draft%20Ver10%20March%2016,%2005.pdf
- 6. Chen, M. L. & Lesko, L. J. (2001). Individual bioequivalence revisited, Clinical Pharmacokinetics, 40 (10), 701-6.
- 7. Chen, M. L. ; Patnaik, R. ; Hauck, W. W. ; Schuirmann, D.J. ; Hyslop, T. & Williams, R. (2000). An individual bioequivalence criterion: regulatory considerations. Stat Med, 19 (20), 2821-42.
- 8. Committee for Proprietary Medicinal Products (CPMP) (2000). Note for guidance on the investigation of bioavailability and bioequivalence, The European Agency for the Evaluation of Medicinal Products (EMEA) – Evaluation of medicines for human use. London, 14 Dec 2000 CPMP/EWP/QWP/1401/98. Available from: http://www.eme.europa.eu/docs/en_GB/ducument_library/Scientific_guideline/2009/09/WC500003519.pdf
- 9. Crawford, P. ; Feely, M. ; Guberman, A. & Kramer, G. (2006). Are there potential problems with generic substitution of antiepileptic drugs? A review of issue, Seizure, 15, 165-176.
- 10. FDA (1992). Guidance for industry, Statistical procedures for bioequivalence studies using a standard two-treatment crossover design. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), July 1992. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072878.pdf
- 11. FDA (1996). Guidance for industry, E6 Good Clinical Practice: Consolidated Guidance. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), April 1996. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf
- 12. FDA (2000). Guidance for industry, Waiver of In vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) August 2000. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf
- 13. FDA (2001a). Guidance for industry, Statistical approaches to establishing bioequivalence. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), January 2001. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf
- 14. FDA (2001b). Guidance for industry, Bioanalytical Method Validation. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), May 2001. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf
- 15. FDA (2003). Guidance for industry, Bioavailability and bioequivalence studies for orally administered drug products – General considerations. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) March 2003. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.
References
1. Banahan, B. F. & Kolassa, E. M. (1997). A physician survey on generic drugs and substitution of critical dose medications, Archive of Internal Medicine, 157, 2080-2088.
2. Benet, L. Z. & Goyan, J. E. (1995). Bioequivalence and narrow therapeutic index drugs, Pharmacotherapy, 15, 433-440.
3. Boix-Montanes A. (2011). Relevance of equivalence assessment of topical products based on the dermatopharmacokinetics approach, European Journal of Pharmaceutical Sciences, 42 (3), 173-9.
4. Central Drugs Standard Control Organization (CDSCO) (2005). Guidelines for bioavailability and bioequivalence studies. Directorate General of Health Services.
5. Ministry of Health and Family Welfare, Government of India, New Delhi. Available from: http://cdsco.nic.in/html/BE%20Guidelines%20Draft%20Ver10%20March%2016,%2005.pdf
6. Chen, M. L. & Lesko, L. J. (2001). Individual bioequivalence revisited, Clinical Pharmacokinetics, 40 (10), 701-6.
7. Chen, M. L. ; Patnaik, R. ; Hauck, W. W. ; Schuirmann, D.J. ; Hyslop, T. & Williams, R. (2000). An individual bioequivalence criterion: regulatory considerations. Stat Med, 19 (20), 2821-42.
8. Committee for Proprietary Medicinal Products (CPMP) (2000). Note for guidance on the investigation of bioavailability and bioequivalence, The European Agency for the Evaluation of Medicinal Products (EMEA) – Evaluation of medicines for human use. London, 14 Dec 2000 CPMP/EWP/QWP/1401/98. Available from: http://www.eme.europa.eu/docs/en_GB/ducument_library/Scientific_guideline/2009/09/WC500003519.pdf
9. Crawford, P. ; Feely, M. ; Guberman, A. & Kramer, G. (2006). Are there potential problems with generic substitution of antiepileptic drugs? A review of issue, Seizure, 15, 165-176.
10. FDA (1992). Guidance for industry, Statistical procedures for bioequivalence studies using a standard two-treatment crossover design. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), July 1992. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072878.pdf
11. FDA (1996). Guidance for industry, E6 Good Clinical Practice: Consolidated Guidance. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), April 1996. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm073122.pdf
12. FDA (2000). Guidance for industry, Waiver of In vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) August 2000. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070246.pdf
13. FDA (2001a). Guidance for industry, Statistical approaches to establishing bioequivalence. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), January 2001. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf
14. FDA (2001b). Guidance for industry, Bioanalytical Method Validation. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), May 2001. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf
15. FDA (2003). Guidance for industry, Bioavailability and bioequivalence studies for orally administered drug products – General considerations. U.S. Department of Health and Human Services. Food and Drug Administration, Center for Drug Evaluation and Research (CDER) March 2003. Available from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf.