Oral Dosage Form Performance Tests: New Dissolution Approaches

Author:

Hauck Walter W.,Foster Thomas,Sheinin Eric,Cecil Todd,Brown William,Marques Margareth,Williams Roger L.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Organic Chemistry,Pharmaceutical Science,Pharmacology,Molecular Medicine,Biotechnology

Reference24 articles.

1. 1. M.-L. Chen. Lipid-based oral dosage forms?regulatory perspective. Am. Pharm. Rev. 5:30?35 (2002).

2. 2. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Bioavailability and Bio-equivalence Studies for Orally Administered Drug Products-General Considerations, Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, Rockville, MD, 2003.

3. 3. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, Rockville, MD, 2000.

4. 4. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Extended-Release Oral Dosage Forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations, Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, Rockville, MD, 1997.

5. 5. U.S. Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Dissolution Testing of Immediate-Release Solid Oral Dosage Forms, Office of Training and Communications, Division of Communications Management, Drug Information Branch, HFD-210, Rockville, MD, 1997.

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