Equivalence by Design for Advanced Dosage Forms and Drug Products - Pharmaceutical Technology

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Equivalence by Design for Advanced Dosage Forms and Drug Products
FDA has been encouraging drug sponsors to use a systematic approach such as quality-by-design principles for pharmaceutical development.

Pharmaceutical Technology
Volume 33, Issue 10, pp. 104-110


1. FDA, Electronic Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Science, Office of Generic Drugs, Rockville, MD), http://www.fda.gov/cder/ob/default.htm, accessed Sept. 21, 2009.

2. "Bioavailability and Bioequivalence Requirements," in Code of Federal Regulations, Title 21, Food and Drugs (General Services Administration, Washington DC, 2009), Part 320.

3. FDA, Critical Path Opportunities for Generic Drugs, May 1, 2007, http://www.fda.gov/oc/initiatives/criticalpath/reports/generic.html, accessed Sept. 21, 2009.

4. D.J. Burgess et al., "Assuring Quality and Performance of Sustained and Controlled Release Parenterals: AAPS Workshop Report," Pharm. Res. 19, 1761–1768 (2002).

5. D.J. Burgess et al., "Assuring Quality and Performance of Sustained and Controlled Release Parenterals: EUFEPS Workshop Report," Eur. J. Pharm. Sci. 21, 769–790 (2004).

6. 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 (Rockville, MD, Aug. 2000).

7. FDA, Interim Guidance: Cholestyramine Powder: In Vitro Bioequivalence (Rockville, MD, July 1993).

8. M.-L. Chen and V.H.L. Lee, "Equivalence-by-Design: Targeting In Vivo Drug Delivery Profile," Pharm. Res. 25, 2723–2730 (2008).

9. FDA, Guidance for Industry: Q8(R1) Pharmaceutical Development (Rockville, MD, June 2009).

10. FDA, Guidance for Industry: Extended Release Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlation (Rockville, MD, Sept. 1997.

11. S.S. Davis et al., "Gamma Scintigraphy in the Evaluation of Pharmaceutical Dosage Forms," J. Nuclear Medicine, 19 (11), 971–986 (1992).

12. G. Meseguer, R. Gurny, and P. Buri, "In Vivo Evaluation of Dosage forms: Application of Gamma Scintigraphy to Nonenteral Routes of Administration," J. Drug Targeting 2, 269-288 (1994).

13. P.H. Layer et al., "Delivery and Fate of Oral Mesalamine Microgranules within the Human Small Intestine," Gastroenterology 108, 1427–1433 (1995).

14. S.P. Newman and I.R. Wilding, "Imaging Techniques for Assessing Drug Delivery in Man," PSTT 2 (5), 181–189 (1999).

15. E. Lundin et al, "Segmental Colonic Transit Studies: Comparison of a Radiological and a Scintigraphic Method," Colorectal Disease: The Official Journal of the Association of Coloproctology of Great Britain and Ireland 9 (4), 344–351 (2007).

16. M.-L. Chen et al., "A Modern View of Excipient Effects on Bioequivalence: Case Study of Sorbitol," Pharm. Res. 24, 73–80 (2007).

17. FDA, "Guidance for Industry: Ethnic Factors in the Acceptability of Foreign Clinical Data," Fed. Regist. 63 (111), 31790–31796 (June 10, 1998).

18. M.-L. Chen, "Confounding Factors for Sex Differences in Pharmacokinetics and Pharmacodynamics: Focus on Dosing Regimen, Dosage Form, and Formulation," Clin. Pharmacol. Ther. 78, 322–329 (2005).


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