Setting Dissolution Specifications for Modified-Release Dosage Forms

Author:

Piscitelli Deborah A.,Young David

Publisher

Springer US

Reference8 articles.

1. The United States Pharmacopeia 23 and The National Formulary 18, The United States Pharmacopeial Convention, Inc. Supp. 1, 1995:2449-2450.

2. Guidance for Industry. Immediate Release Solid Oral Dosage Forms. Scale-Up and Post-Approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo Bioequivalence Documentation. Center for Drug Evaluation and Research, November 1995.

3. 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. Center for Drug Evaluation and Research, May 1996.

4. Guidance for Industry. Extended Release Solid Oral Dosage Forms Development, Evaluation and Application of In Vitro/In Vivo Correlations. Center for Drug Evaluation and Research, July 1, 1996.

5. Shah VP and Williams RL. In vivo and In vitro correlations: scientific and regulatory perspectives, in Generics and Bioequivalence. CRC Press, Inc., Boca Raton, Florida, 1994. 108–109.

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