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In Vivo Predictive Dissolution (IPD) and Biopharmaceutical Modeling and Simulation: Future Use of Modern Approaches and Methodologies in a Regulatory Context
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Pharmacy, Department of Pharmacy.
Med Prod Agcy, Uppsala, Sweden..
Janssen Pharmaceut NV, Janssen Res & Dev, Turnhoutseweg 30, B-2340 Beerse, Belgium..
Sanofi US, 55 Corp Dr, Bridgewater, NJ 08807 USA..
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2017 (English)In: Molecular Pharmaceutics, ISSN 1543-8384, E-ISSN 1543-8392, Vol. 14, no 4, 1307-1314 p.Article in journal (Refereed) Published
Abstract [en]

The overall objective of OrBiTo, a project within Innovative Medicines Initiative (IMI), is to streamline and optimize the development of orally administered drug products through the creation and efficient application of biopharmaceutics tools. This toolkit will include both experimental and computational Models developed on improved understanding of the highly dynamic gastrointestinal (GI) physiology relevant to the GI absorption of drug products in both fasted and fed states. A part of the annual OrBiTo meeting in 2015 was dedicated: to the presentation of the most recent progress in the development of the regulatory use of PBPK in silk() modeling, in vivo predictive dissolution (IPD) tests, and their application to biowaivers. There are still several areas for improvement of in vitro dissolution testing by means of generating results relevant for the intraluminal conditions in the GI tract. The major opportunity is probably in combining IPD testing and physiologically based in silico models where the in vitro data provide input to the absorption predictions. The OrBiTo project and other current research projects include-definition of test media representative for the more distal parts of the GI tract, models capturing supersaturation and precipitation phenomena, and influence of motility waves on shear and other forces of hydrodynamic origin, addressing the inter individual variability in composition and characteristics of GI fluids, food effects, definition of biorelevant buffer systems, and intestinal water volumes. In conclusion, there is currently a mismatch between the extensive industrial usage of modern in vivo predictive tools and very limited inclusion of such data in regulatory files. However, there is a great interest among all stakeholders to introduce recent progresses in prediction of in vivo GI drug absorption into regulatory context.

Place, publisher, year, edition, pages
2017. Vol. 14, no 4, 1307-1314 p.
Keyword [en]
Biopharmaceutics Classification System, in vivo predictive dissolution, biorelevant dissolution, theoretical modeling, PBPK, bioequivalence, intestinal drug absorption, generic drugs
National Category
Pharmaceutical Sciences
Identifiers
URN: urn:nbn:se:uu:diva-321439DOI: 10.1021/acs.molpharmaceut.6b00824ISI: 000398426100032PubMedID: 28195732OAI: oai:DiVA.org:uu-321439DiVA: diva2:1094151
Available from: 2017-05-09 Created: 2017-05-09 Last updated: 2017-05-09

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