1. USP38 Chapter <1088>.
2. FDA Guidance for Industry. Extended release oral solid dosage forms: development, evaluation, and application of in vitro/in vivo correlations; September 1997.
3. USP38 Chapter <1090>: Assessment of drug product performance-bioavailability, bioequivalence, and dissolution.
4. FDA Draft Guidance for Industry: Industry. Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system; 2015.
5. FDA Guidance for Industry. SUPAC-IR: immediate release solid oral dosage forms scale-up and postapproval changes: chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation; 1995.