Draft Guidance for Industry Extended-Release Solid Oral Dosage Forms
This draft guidance provides recommendations to pharmaceutical scientists related to various aspects of in vitro/in vivo correlations (IVIVC) for oral extended-release (ER) drug products particularly as utilized in the NDA/ANDA review process. It presents a comprehensive perspective on methods of developing IVIVC, appropriate means of evaluating the predictability of IVIVC, and relevant applications for IVIVC in the areas of changes (e.g., formulation, equipment, process, and manufacturing site) and setting dissolution specifications. To access the final guidance on the WWW, connect to theFDA home page at http://www.fda.gov/CDER/ and go to the “Regulatory Guidance” section.
KeywordsPrediction Error Dosage Form Drug Product Dissolution Profile Dissolution Time
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- 1.“An Introduction to the Bootstrap”, B. Efron and R.J. Tibshirani, Chapman & Hill, New York, 1993, pp. 237–257.Google Scholar
- 2.“Draft Guidance for Industry: Modified Release Solid Oral Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and in vivo Bioequivalence Documentation”, U.S. Department of Health and Human Services, Food and Drug Administration, July 1996.Google Scholar
- 3.“Mathematical comparison of curves with an emphasis on dissolution profiles”, J.W.Moore and H.H.Flanner, presented at the AAPS National Meeting, November 1994. Personal Communication from AAI Inc., Wilmington, NC 28405.Google Scholar
- 4.“Report of the Workshop on CR Dosage Forms: Issues and Controversiesȝ, J.P. Skelly et al., Pharmaceutical Research, 4(1), 1987, pp. 75–78.Google Scholar
- 5.“In-vitro/In-Vivo Correlation for Extended-Release Oral Dosage Forms”, USP PF Stimuli Article, July 1988, pp. 4160-4161.Google Scholar
- 6.“Report of Workshop on In vitro and in vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms”, J.P. Skelly et al., Journal of Pharmaceutical Sciences, 79(9), September 1990, pp. 849–854.Google Scholar
- 7.“In Vitro in vivo Evaluation of Dosage Forms”, USP XXIII chapter <1088>, United States Pharmacopoeal Convention, Inc., pp. 1927-1929.Google Scholar
- 8.Workshop II report “Scale-up of Oral Extended Release Dosage Forms”, J.P. Skelly et al., Pharmaceutical Research, 10(12), 1993, pp. 1800–1805.Google Scholar