1. 21 CFR 320. 21 CFR 320 Bioavailability and bioequivalence requirements.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=320.1
. Accessed 9 July 2013
2. AAPS (1997) Science and regulations: individual and population bioequivalence—regulatory approaches and issues. America Association of Pharmaceutical Scientists (AAPS) Annual Meeting, Nov 2–6 1997, Boston
3. AAPS (1998) Scientific and regulatory issues in product quality: narrow therapeutic index drugs and individual bioequivalence. American Association of Pharmaceutical Scientists (AAPS) Workshop, Mar 16–18 1998, Arlington
4. AAPS (1999) Individual bioequivalence: realities and implementation. American Association of Pharmaceutical Scientists (AAPS) International Workshop, Aug 30–Sep 1 1999, Montreal
5. Adams WP, Ahrens RC, Chen ML, Christopher D, Chowdhury BA, Conner DP, Dalby R, Fitzgerald K, Hendeles L, Hickey AJ, Hochhaus G, Laube BL, Lucas P, Lee SL, Lyapustina S, Li B, O’Connor D, Parikh N, Parkins DA, Peri P, Pitcairn GR, Riebe M, Roy P, Shah T, Singh GJ, Sharp SS, Suman JD, Weda M, Woodcock J, Yu L (2010) Demonstrating bioequivalence of locally acting orally inhaled drug products (OIPs): workshop summary report. J Aerosol Med Pulm Drug Deliv 23:1–29