1. U.S. Department of Health and Human Services, 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 correlation. September 1997.
2. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: nonsterile semisolid dosage forms. Scale-up and postapproval changes: chemistry, manufacturing and controls, in vitro release testing, and in vivo bioequivalence documentation. May 1997.
3. U.S. Department of Health and Human Services, 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. December 2017.
4. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. 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 bioequivalence documentation. November 1995.
5. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for industry: dissolution testing of immediate release solid oral dosage forms. August 1997.