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Six years of progress in the oral biopharmaceutics area - A summary from the IMI OrBiTo project
AstraZeneca R&D, S-43183 Molndal, Sweden..
Pfizer, Tadworth, Surrey, England..
Katholieke Univ Leuven, Leuven, Belgium..
Sanofi Aventis, Paris, France..
Vise andre og tillknytning
2020 (engelsk)Inngår i: European journal of pharmaceutics and biopharmaceutics, ISSN 0939-6411, E-ISSN 1873-3441, Vol. 152, s. 236-247Artikkel i tidsskrift (Fagfellevurdert) Published
Abstract [en]

OrBiTo was a precompetitive collaboration focused on the development of the next generation of Oral Biopharmaceutics Tools. The consortium included world leading scientists from nine universities, one regulatory agency, one non-profit research organisation, three small/medium sized specialist technology companies together with thirteen pharmaceutical companies. The goal of the OrBiTo project was to deliver a framework for rational application of predictive biopharmaceutics tools for oral drug delivery. This goal was achieved through novel prospective investigations to define new methodologies or refinement of existing tools. Extensive validation has been performed of novel and existing biopharmaceutics tools using historical datasets supplied by industry partners as well as laboratory ring studies. A combination of high quality in vitro and in vivo characterizations of active drugs and formulations have been integrated into physiologically based in silico biopharmaceutics models capturing the full complexity of gastrointestinal drug absorption and some of the best practices has been highlighted. This approach has given an unparalleled opportunity to deliver transformational change in European industrial research and development towards model based pharmaceutical product development in accordance with the vision of model-informed drug development.

sted, utgiver, år, opplag, sider
ELSEVIER , 2020. Vol. 152, s. 236-247
Emneord [en]
Biopharmaceutics, PBPK, IVIVC, Dissolution, Drug absorption, Permeability
HSV kategori
Identifikatorer
URN: urn:nbn:se:uu:diva-418708DOI: 10.1016/j.ejpb.2020.05.008ISI: 000540837600024PubMedID: 32446960OAI: oai:DiVA.org:uu-418708DiVA, id: diva2:1464677
Tilgjengelig fra: 2020-09-07 Laget: 2020-09-07 Sist oppdatert: 2020-09-07bibliografisk kontrollert

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