1. Sechenov First Moscow State Medical University
Scientific Center for Expertise of Medical Products 2. Scientific Center for Expertise of Medical Products 3. Sechenov First Moscow State Medical University
Abstract: The review deals with the modern tool for modeling of drug behavior in vivo, - the dissolution test in biorelevant media, imitating gastrointestinal fluids. The formulations and preparation methods of fasted state simulation intestinal fluid, FaSSIF and fed state simulation intestinal fluid, FeSSIF, are defined. In addition, the dissolution characteristics of APIs from different BCS classes in biorelevant media are described. Possible applications of biorelevant media in regulatory practice and science are also shown.
Reference: Ramenskaya G.V., Shohin I.E., Savchenko A.Y., Volkova E.A., The dissolution test in biorelevant media as a prognostic tool for modeling of drug behavior in vivo, Biomeditsinskaya khimiya, 2011, vol:
1. Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms (2006) Technical Report Series, No 937, 40th Report, Annex 7 of WHO Expert Committee on Specifications for Pharmaceutical Preparations. World Health Organization (WHO), Geneva, Switzerland.
7. Guidance on the Investigation of Bioequivalence (2010) European Medicines Agency (EMA), Committee for Medicinal Products of Human Use (CHMP).
8. Guidances for industry: Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a Biopharmaceutics Classification System (2001) US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER).
9. Metodicheskie rekomendatsii dlya razrabotchikov i proizvoditelej lekarstvennykh sredstv po otsenke ehkvivalentnosti in vitro genericheskikh lekarstvennykh sredstv soglasno protsedure "biovejver". Utv. Rozdravnadzorom (2010). Remedium, M.
10. Marques M. (2004) Dissolution Technol., 11(2), 16. CrossRef
11. Dressman J., Kramer J. (2005) Pharmaceutical Dissolution Testing, Boca Raton: Taylor & Francis.