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

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

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

References

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).


ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
33%
Breakthrough designations
11%
Protecting the supply chain
39%
Expedited reviews of drug submissions
11%
More stakeholder involvement
6%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: Pharmaceutical Technology,
Click here