1. CDER. Guidance for industry, immediate release solid oral dosage forms, scale-up and postapproval changes. Rockville, MD 208551995.
2. FDA. Guidance for industry, SUPAC-MR: modified release solid oral dosage forms scale-up and postapproval changes: chemistry, manufacturing, and controls; in vitro dissolution testing and in vivo bioequivalence documentation. CMC 8. Rockville, MD 20857: Center for Drug Evaluation and Research (CDER); 1997.
3. EMEA. Guidance on pharmaceutical Develo. London, E14 4HB, UK; 2009.
4. FDA. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products—general considerations. In: FDA, editor. Rockville, MD; 2003.
5. Midha KK, McKay G. Bioequivalence; its history, practice, and future. AAPS J. 2009;11(4):664–70. doi: 10.1208/s12248-009-9142-z .