สำนักงานราชบัณฑิตยสภา

การทดสอบการละลายของยาสามัญ 134 The Journal of the Royal Society of Thailand Volume 40 Number 1 January-March 2015 system. Rockville, MD. Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, Md, USA. 1997. Guidance for Industry: Immediate Release Solid Oral Dosage Forms. Scale-Up and Post approval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing and In Vivo BE Documentation, US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Rockville, Md, USA, 1995. Jantratid, E., Prakongpan, S., Amidon, G.L., Dressman, J.B. 2006. “Feasibility of biowaiver extension to biopharmaceutics classification system class III drug products: cimetidine.” Clinical Pharmacokinetics 45(4): 385-399. Noyes A.A, Whitney W.S. 1897. J Am Chem Soc. The rate of solution of solid substances in their own solutions. 19, 930-934. Orange book: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm# Therapeutic%20 Equivalence-Related%20Terms Accessed 26 October 2014. The European Medicines Agency, Committee for Proprietary Medicinal Products (CPMP). 2010. Guidance on the investigation of bioequivalence. United States Pharmacopeia (USP), U.S. Pharmacopeial Convention, Inc. Rockville, MD. Zhang, Y., Huo, M., Zhou, J. et al. 2010. “DDSolver: an add-in program for modeling and comparison of drug dissolution profiles”, AAPS Journal, vol. 12, no. 3, pp. 263–271.