Coba jelasin Equilab International dari Bioekuivalensi dong

Hussain AS, et al. The Biopharmaceutics Classification System: Highlights of the FDA's Draft Guidance Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration.

Rx index, specialized medical publication - online directory of drug bioequivalence. Intended exclusively for doctors of all specialties, pharmacists, clinical pharmacists, students of pharmaceutical faculties of higher medical (pharmaceutical) educational establishments of the III-IV level of accreditation, operators of the pharmaceutical market.

Mills D (2005). Regulatory Agencies Do Not Require Clinical Trials To Be Expensive International Biopharmaceutical Association: IBPA Publications.

FDA CDER Office of Generic Drugs – further U.S. information on bioequivalence testing and generic drugs

Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms. WHO Technical Report Series, No. 937, 2006, Annex 8.

Guidance for organizations performing in vivo bioequivalence studies (revision). WHO Technical Report Series 996, 2016, Annex 9.

General background notes and list of international comparator pharmaceutical products. WHO Technical Report Series 1003, 2017, Annex 5.

WHO List of International Comparator products (September 2016)