Editing Bioequivalence (section)

== External links ==

* Hussain AS, et al. [http://www.dissolutiontech.com/DTresour/599articles/Biopharm_Class2_copy.html The Biopharmaceutics Classification System: Highlights of the FDA's Draft Guidance] Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration.
* Mills D (2005). [https://web.archive.org/web/20051103203712/http://www.ibpassociation.org/clintrials.html Regulatory Agencies Do Not Require Clinical Trials To Be Expensive] International Biopharmaceutical Association: IBPA Publications.
* [https://web.archive.org/web/20110318232534/https://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm119100.htm FDA CDER Office of Generic Drugs] &ndash; further U.S. information on bioequivalence testing and generic drugs
*[https://www.who.int/medicines/areas/quality_safety/quality_assurance/ProposalWaiveVivoBioequivalenceRequirementsModelListEssentialMedicinesImmediateReleaseSolidOralDosageFormsTRS937Annex8.pdf?ua=1 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. 	
* [https://www.who.int/medicines/publications/pharmprep/WHO_TRS_996_annex09.pdf?ua=1 Guidance for organizations performing in vivo bioequivalence studies (revision)]. WHO Technical Report Series 996, 2016, Annex 9.
* [https://www.who.int/medicines/areas/quality_safety/quality_assurance/Annex5.pdf?ua=1 General background notes and list of international comparator pharmaceutical products]. WHO Technical Report Series 1003, 2017, Annex 5.	
* [https://web.archive.org/web/20140329211802/http://www.who.int/medicines/areas/quality_safety/quality_assurance/regulatory_standards/en/ WHO List of International Comparator products] (September 2016)

{{Pharmacology}}

[[Category:Pharmacokinetics]]
[[Category:Clinical research]]
[[Category:Life sciences industry]]