1. Food and Drug Administration. Guidance for industry: extended release oral dosage forms: development, evaluation, and application of in vitro/in vivo correlations US. Washington, DC: Department of Health and Human Services, Food and DrugAdministration Center for Drug Evaluation and Research (CDER); 1997.
2. Food and Drug Administration. Quality by design for ANDAs: an example for immediate—release dosage forms. Washington,DC: Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER); 2012.
3. Food and Drug Administration. Quality by design for ANDAs: an example for modified dosage forms. Washington, DC: Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER); 2011.
4. Food and Drug Administration. Guidance for industry: bioavailability and bioequivalence studies for orally administered drug products—general considerations. Washington, DC: Department of Health and Human Services, Food and Drug Administration Center for Drug Evaluation and Research (CDER); 2003.
5. Dunne A. Approaches to developing in vitro – in vitro correlation models. In: Chiliruki DM, Sunkara G, Young D, editors. Drugs and the pharmaceutical sciences, vol 165, pharmaceutical product development in vivo in vitro correlation, Informa. 2007. pp. 47–69.