Continuing equivalence: Is there an end to the story?

Journal of Generic Medicines

Volumn 5, Issue 4, 2008, Pages 297-304

  Williams, Roger L ^a,b   Shah, Vinod P ^b  

^a United States Pharmacopeial Convention   (United States)

^b UNIVERSITY OF SÃO PAULO   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 54749126700     PISSN: 17411343     EISSN: 17417090     Source Type: Journal    
DOI: 10.1057/jgm.2008.19     Document Type: Article

References (26)

1. ICH, Q8: Pharmaceutical Development and Annex,http://www.ich.org/cache/ compo/276-254-1.html, accessed 10th June, 2008.
2. ICH, Q9: Quality Risk Management, 2005, http://www.ich.org/cache/compo/ 276-254-1.html, accessed 10th June, 2008.
3. ICH, Q10: Pharmaceutical Quality System, http://www.ich.org/cache/compo/ 276-254-1.html, accessed 10th June, 2008.
4. WHO. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability, in WHO Technical Report Series 937, Annex 7, pp. 347-390, http://www.who.int/ medicines/areas/quality_safety/quality_assurance/ regulatory_standards/en/, accessed 10th June, 2008.
5. 21 Code of Federal Regulations 314.94(a)(3).
6. WHO. Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products, WHO Technical Report Series 902, Annex 11, 161-180, http://www.who.int/medicines/publications/pharmprep/en/, accessed 10th June, 2008.
7. FDA. Changes to an approved NDA or ANDA. http://www.fda.gov/cder/fdama/ sections.htm, accessed 9th June, 2008.
8. 21 CFR 320.21.
9. WHO. Multisource (generic) pharmaceutical products: Guidelines on registration requirements to establish interchangeability, in WHO Technical Report Series 863, Annex 9, pp. 114-154, http://www.who.int/ medicines/areas/quality_safety/quality_assurance/ regulatory_standards/en/, accessed 10th June, 2008.
10. FDA. Guidance for industry: Bioavailability and bioequivalence studies for orally administered drug products - general considerations. www.fda.gov/cder/guidance/3615fnl.htm, accessed 10th June, 2008.
11. Areas for further harmonization of BE requirements were considered at a conference symposium chaired by Mario Tanguay prior to a meeting of the International General Pharmaceutical Alliance 28th November, 2007.
12. FDA. Guidance for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system. www.fda.gov/cder/ guidance/3618fnl.pdf, accessed 10th June, 2008.
13. Yu, L. X., Amidon, G. L., Polli, J. E., Zhao, H., Mehta, M. U, Conner, D. P., Shah, V. P., Lesko, L. J., Chen, M. L., Lee, V H. & Hussain, A. S. (2002). Biopharmaceutics classification system: The scientific basis for biowaver extensions. Pharm. Res. 19, 921-925.
14. FDA. Guidance for industry: Statistical approaches to establishing bioequivalence, http://www.fda.gov/cder/guidance/3616fnl.htm, accessed 10th June, 2008.
15. Haidar, S. H., Davit, B., Chen, M. L., Conner, D., Lee, L. M., Qian, H. L., Lionberger, R., Makhlouf, E, Patel, D., Schuirmann, D. J. & Yu, L. X. (2008). Bioequivalence approaches for highly variable drugs and drug products. Pharm. Res. 25, 237-241.
16. Sheiner, L. B. (1992). Bioequivalence revisited. Stat. Med. 11 1777-1788.
17. Schall, R. (1995). Assessment of individual and population bioequivalence using the probability that bioavailabilities are similar. Biometrics 51, 615-626.
18. Schuirmann, D. J. (1987). A comparison of two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharmaceutics. 15, 657-680.
19. Chen, M.-L., Straughn, A. B., Sadrieh, N., Meyer, M., Faustino, P. J., Ciavarella, A. B., Meibohm, B., Yates, C. R. & Hussain, A. S. (2007). A modern view of excipient effects on bioequivalence: Case study of sorbitol. Pharm. Res. 24, 73-80.
20. Levyin, G. (1991). Pharmacodynamic considerations in bioavailability and bioequivalence assessmentsin Crommelin, D. J. A. and Midha, K. K. (eds.), Topics in Pharmaceutical Sciences, Medpharm Scientific Publishers, Stuttgaet, Germany, pp. 243-257.
21. FDA. Guidance for industry: Immediate-release solid oral dosage forms scale-up and postapproval changes: Chemistry, manufacturing, and controls; In Vitro dissolution testing and In vivo bioequivalence documentation, www.fda.gov/cder/guidance/cmc5.pdf, accessed 10th June, 2008.
22. FDA. Guidance for industry: SUPAC-MR: Modified release solid oral dosage forms scale-up and postapproval changes: Chemistry, manufacturing, and controls; In Vitro dissolution testing and In Vivo bioequivalence documentation, www.fda.gov/cder/guidance/1214fnl.pdf, accessed 10th June, 2008.
23. FDA. Guidance for industry: ANDAs: Pharmaceutical solid polymorphism chemistry, manufacturing, and controls information, www.fda.gov/cder/ guidance/7590fnl.htm, accessed 25th June, 2008.
24. FDA. Modernization Act of 1997, Pub. L. 105-115 §115 (1997).
25. USP. Submission guidelines. http://www.usp.org/USPNF/submitMonograph/ subGuide.html, accessed 10th June, 2008.
26. EDQM. Certification of suitability to the monographs of the European Pharmacopoeia (revised version), http://www.edqm.eu/site/ resultat_de_recherche-519.html, accessed 13th May, 2008.