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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00006830naa a2200913 4500
001oai:DiVA.org:uu-361061
003SwePub
008180920s2017 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3610612 URI
0247 a https://doi.org/10.1016/j.ejps.2016.09.0272 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Margolskee, Alisonu Univ Manchester, Manchester M13 9PL, Lancs, England4 aut
2451 0a IMI - oral biopharmaceutics tools project - evaluation of bottom-up PBPK prediction success part 1 :b Characterisation of the OrBiTo database of compounds
264 1b Elsevier BV,c 2017
338 a print2 rdacarrier
520 a Predicting oral bioavailability (F-oral) is of importance for estimating systemic exposure of orally administered drugs. Physiologically-based pharmacokinetic (PBPK) modelling and simulation have been applied extensively in biopharmaceutics recently. The Oral Biopharmaceutical Tools (OrBiTo) project (Innovative Medicines Initiative) aims to develop and improve upon biopharmaceutical tools, including PBPK absorption models. A large-scale evaluation of PBPK models may be considered the first step. Here we characterise the OrBiTo active pharmaceutical ingredient (API) database for use in a large-scale simulation study. The OrBiTo database comprised 83 APIs and 1475 study arms. The database displayed a median logP of 3.60 (2.40-4.58), human blood-to-plasma ratio of 0.62 (0.57-0.71), and fraction unbound in plasma of 0.05 (0.01-0.17). The database mainly consisted of basic compounds (48.19%) and Biopharmaceutics Classification System class II compounds (55.81%). Median human intravenous clearance was 16.9 L/h (interquartile range: 11.6-43.6 L/h; n = 23), volume of distribution was 80.8 L (54.5-239 L; n = 23). The majority of oral formulations were immediate release (IR: 87.6%). Human Foral displayed a median of 0.415 (0.203-0.724; n = 22) for IR formulations. The OrBiTo database was found to be largely representative of previously published datasets. 43 of the APIs were found to satisfy the minimum inclusion criteria for the simulation exercise, and many of these have significant gaps of other key parameters, which could potentially impact the interpretability of the simulation outcome. However, the OrBiTo simulation exercise represents a unique opportunity to perform a large-scale evaluation of the PBPK approach to predicting oral biopharmaceutics.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Farmaceutiska vetenskaper0 (SwePub)301012 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Pharmaceutical Sciences0 (SwePub)301012 hsv//eng
653 a Physiologically-based pharmacokinetics (PBPK)
653 a Modelling and simulation (M&S)
653 a Absorption
653 a Oral bioavailability (F-oral)
653 a Biopharmaceutics
653 a Drug database
7001 a Darwich, Adam S.u Univ Manchester, Manchester M13 9PL, Lancs, England4 aut
7001 a Pepin, Xavieru AstraZeneca, London, England;Sanofi, Paris, France4 aut
7001 a Pathak, Shriram M.u Simcyp Ltd, Sheffield, S Yorkshire, England4 aut
7001 a Bolger, Michael B.u Simulat Plus Inc, Lancaster, CA USA4 aut
7001 a Aarons, Leonu Univ Manchester, Manchester M13 9PL, Lancs, England4 aut
7001 a Rostami-Hodjegan, Aminu Simcyp Ltd, Sheffield, S Yorkshire, England;Univ Manchester, Manchester M13 9PL, Lancs, England4 aut
7001 a Angstenberger, Jonasu AbbVie, Wiesbaden, Germany4 aut
7001 a Graf, Franziskau AbbVie, Wiesbaden, Germany4 aut
7001 a Laplanche, Loicu AbbVie, Wiesbaden, Germany4 aut
7001 a Mueller, Thomasu AbbVie, Wiesbaden, Germany4 aut
7001 a Carlert, Sarau AstraZeneca, Gothenburg, Sweden4 aut
7001 a Daga, Pankaju AstraZeneca, New York, NY USA4 aut
7001 a Murphy, Donalu AstraZeneca, London, England4 aut
7001 a Tannergren, Christeru AstraZeneca, Gothenburg, Sweden4 aut
7001 a Yasin, Mohammedu AstraZeneca, London, England4 aut
7001 a Greschat-Schade, Susanneu Bayer Pharma AG, Berlin, Germany4 aut
7001 a Mueck, Wolfgangu Bayer Pharma AG, Berlin, Germany4 aut
7001 a Muenster, Uweu Bayer Pharma AG, Berlin, Germany4 aut
7001 a van der Mey, Dorinau Bayer Pharma AG, Berlin, Germany4 aut
7001 a Frank, Kerstin Juliau Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany4 aut
7001 a Lloyd, Richardu GlaxoSmithKline, Brentford, Middx, England4 aut
7001 a Adriaenssen, Lieveu Janssen, Beerse, Belgium4 aut
7001 a Bevernage, Janu Janssen, Beerse, Belgium4 aut
7001 a De Zwart, Loeckieu Janssen, Beerse, Belgium4 aut
7001 a Swerts, Dominiqueu Janssen, Beerse, Belgium4 aut
7001 a Tistaert, Christopheu Janssen, Beerse, Belgium4 aut
7001 a Van Den Bergh, Anu Janssen, Beerse, Belgium4 aut
7001 a Van Peer, Achielu Janssen, Beerse, Belgium4 aut
7001 a Beato, Stefaniau Novartis, Basel, Switzerland4 aut
7001 a Nguyen-Trung, Anh-Thu4 aut
7001 a Bennett, Joanneu Pfizer, Tadworth, Middx, England4 aut
7001 a McAllister, Marku Pfizer, Tadworth, Middx, England4 aut
7001 a Wong, Meiu Pfizer, Tadworth, Middx, England4 aut
7001 a Zane, Patriciau Sanofi, Bridgewater, NJ USA4 aut
7001 a Ollier, Celineu Sanofi, Paris, France4 aut
7001 a Vicat, Pascaleu Sanofi, Paris, France4 aut
7001 a Kolhmann, Markusu Sanofi, Frankfurt, Germany4 aut
7001 a Marker, Alexanderu Sanofi, Paris, France4 aut
7001 a Brun, Priscillau Sanofi, Paris, France4 aut
7001 a Mazuir, Florentu Sanofi, Paris, France4 aut
7001 a Beilles, Stephaneu Sanofi, Paris, France4 aut
7001 a Venczel, Martau Sanofi, Frankfurt, Germany4 aut
7001 a Boulenc, Xavieru Sanofi, Paris, France4 aut
7001 a Loos, Petrau Sanofi, Frankfurt, Germany4 aut
7001 a Lennernäs, Hansu Uppsala universitet,Institutionen för farmaci4 aut0 (Swepub:uu)hanslenn
7001 a Abrahamsson, Bertilu AstraZeneca, Gothenburg, Sweden4 aut
7102 a Univ Manchester, Manchester M13 9PL, Lancs, Englandb AstraZeneca, London, England;Sanofi, Paris, France4 org
7730 t European Journal of Pharmaceutical Sciencesd : Elsevier BVg 96, s. 598-609q 96<598-609x 0928-0987x 1879-0720
8564 u https://www.research.manchester.ac.uk/portal/files/46273617/Margolskee_2016_IMI_ORBITO_1.pdf
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-361061
8564 8u https://doi.org/10.1016/j.ejps.2016.09.027

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