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2. Food and Drug Administration. Guidance for Industry: Immediate Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing and In Vivo BE Documentation. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 1995.
3. Food and Drug Administration. Guidance for Industry: Nonsterile Semisolid Dosage Forms. Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls; In Vitro Release Testing and In Vivo BE Documentation. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 1997.
4. Food and Drug Administration. Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 1997.
5. Food and Drug Administration. Guidance for Industry: SUPAC-MR: Modified Release Solid Oral Dosage Forms. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; 1997.