Sökning: onr:"swepub:oai:DiVA.org:uu-361078" > IMI - Oral biopharm...
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000 | 07705naa a2201033 4500 | |
001 | oai:DiVA.org:uu-361078 | |
003 | SwePub | |
008 | 180920s2017 | |||||||||||000 ||eng| | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3610782 URI |
024 | 7 | a https://doi.org/10.1016/j.ejps.2016.09.0372 DOI |
040 | a (SwePub)uu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Darwich, Adam S.u Univ Manchester, Manchester M13 9PL, Lancs, England4 aut |
245 | 1 0 | a IMI - Oral biopharmaceutics tools project - Evaluation of bottom-up PBPK prediction success part 3 :b Identifying gaps in system parameters by analysing In Silico performance across different compound classes |
264 | 1 | b Elsevier BV,c 2017 |
338 | a print2 rdacarrier | |
520 | a Three Physiologically Based Pharmacokinetic software packages (GI-Sim, Simcyp (R) Simulator, and GastroPlus (TM)) were evaluated as part of the Innovative Medicine Initiative Oral Biopharmaceutics Tools project (OrBiTo) during a blinded "bottom-up" anticipation of human pharmacokinetics. After data analysis of the predicted vs. measured pharmacokinetics parameters, it was found that oral bioavailability (F-oral) was underpredicted for compounds with low permeability, suggesting improper estimates of intestinal surface area, colonic absorption and/or lack of intestinal transporter information. Foralwas also underpredicted for acidic compounds, suggesting overestimation of impact of ionisation on permeation, lack of information on intestinal transporters, or underestimation of solubilisation of weak acids due to less than optimal intestinal model pH settings or underestimation of bile micelle contribution. F-oral was overpredicted for weak bases, suggesting inadequate models for precipitation or lack of in vitro precipitation information to build informed models. Relative bioavailability was underpredicted for both high logP compounds as well as poorly water-soluble compounds, suggesting inadequate models for solubility/dissolution, underperforming bile enhancement models and/or lack of biorelevant solubility measurements. These results indicate areas for improvement in model software, modelling approaches, and generation of applicable input data. However, caution is required when interpreting the impact of drug-specific properties in this exercise, as the availability of input parameters was heterogeneous and highly variable, and the modellers generally used the data "as is" in this blinded bottom-up prediction approach. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Farmaceutiska vetenskaper0 (SwePub)301012 hsv//swe |
650 | 7 | a 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 | |
700 | 1 | a Margolskee, Alisonu Univ Manchester, Manchester M13 9PL, Lancs, England4 aut |
700 | 1 | a Pepin, Xavieru AstraZeneca, London, England;Sanofi, Paris, France4 aut |
700 | 1 | a Aarons, Leonu Univ Manchester, Manchester M13 9PL, Lancs, England4 aut |
700 | 1 | a Galetin, Aleksandrau Univ Manchester, Manchester M13 9PL, Lancs, England4 aut |
700 | 1 | a Rostami-Hodjegan, Aminu Univ Manchester, Manchester M13 9PL, Lancs, England;Simcyp Ltd, Sheffield, S Yorkshire, England4 aut |
700 | 1 | a Carlert, Sarau AstraZeneca, Gothenburg, Sweden4 aut |
700 | 1 | a Hammarberg, Mariau AstraZeneca, Gothenburg, Sweden4 aut |
700 | 1 | a Hilgendorf, Constanzeu AstraZeneca, Gothenburg, Sweden4 aut |
700 | 1 | a Johansson, Pernillau AstraZeneca, Gothenburg, Sweden4 aut |
700 | 1 | a Karlsson, Evau AstraZeneca, Gothenburg, Sweden4 aut |
700 | 1 | a Murphy, Donalu AstraZeneca, London, England4 aut |
700 | 1 | a Tannergren, Christeru AstraZeneca, Gothenburg, Sweden4 aut |
700 | 1 | a Thorn, Helenau AstraZeneca, Gothenburg, Sweden4 aut |
700 | 1 | a Yasin, Mohammedu AstraZeneca, London, England4 aut |
700 | 1 | a Mazuir, Florentu Sanofi, Paris, France4 aut |
700 | 1 | a Nicolas, Olivieru Sanofi, Paris, France4 aut |
700 | 1 | a Ramusovic, Sergeju Sanofi, Frankfurt, Germany4 aut |
700 | 1 | a Xu, Christineu Sanofi, Bridgewater, NJ USA4 aut |
700 | 1 | a Pathak, Shriram M.u Simcyp Ltd, Sheffield, S Yorkshire, England4 aut |
700 | 1 | a Korjamo, Timou Orion Pharma, Espoo, Finland4 aut |
700 | 1 | a Laru, Johannau Orion Pharma, Espoo, Finland;AstraZeneca, London, England4 aut |
700 | 1 | a Malkki, Jussiu Orion Pharma, Espoo, Finland4 aut |
700 | 1 | a Pappinen, Sariu Orion Pharma, Espoo, Finland4 aut |
700 | 1 | a Tuunainen, Johannau Orion Pharma, Espoo, Finland4 aut |
700 | 1 | a Dressman, Jenniferu Goethe Univ Frankfurt Am Main, Frankfurt, Germany4 aut |
700 | 1 | a Hansmann, Simoneu Goethe Univ Frankfurt Am Main, Frankfurt, Germany4 aut |
700 | 1 | a Kostewicz, Edmundu Goethe Univ Frankfurt Am Main, Frankfurt, Germany4 aut |
700 | 1 | a He, Handanu Novartis, New York, NY USA4 aut |
700 | 1 | a Heimbach, Tychou Novartis, New York, NY USA4 aut |
700 | 1 | a Wu, Fanu Novartis, New York, NY USA4 aut |
700 | 1 | a Hoft, Carolinu AbbVie, Wiesbaden, Germany4 aut |
700 | 1 | a Pang, Yanu AbbVie, Wiesbaden, Germany4 aut |
700 | 1 | a Bolger, Michael B.u Simulat Plus Inc, Lancaster, CA USA4 aut |
700 | 1 | a Huehn, Evau Simulat Plus Inc, Lancaster, CA USA4 aut |
700 | 1 | a Lukacova, Vierau Simulat Plus Inc, Lancaster, CA USA4 aut |
700 | 1 | a Mullin, James M.u Simulat Plus Inc, Lancaster, CA USA4 aut |
700 | 1 | a Szeto, Ke X.u Simulat Plus Inc, Lancaster, CA USA4 aut |
700 | 1 | a Costales, Chesteru Pfizer, New York, NY USA4 aut |
700 | 1 | a Lin, Jianu Pfizer, New York, NY USA4 aut |
700 | 1 | a McAllister, Marku Pfizer, Tadworth, Middx, England4 aut |
700 | 1 | a Modi, Swetau Pfizer, New York, NY USA4 aut |
700 | 1 | a Rotter, Charlesu Pfizer, New York, NY USA4 aut |
700 | 1 | a Varma, Manthenau Pfizer, Tadworth, Middx, England4 aut |
700 | 1 | a Wong, Meiu Pfizer, Tadworth, Middx, England4 aut |
700 | 1 | a Mitra, Amitavau Merck Sharp & Dohme Ltd, Hoddesdon, Herts, England4 aut |
700 | 1 | a Bevernage, Janu Janssen, Beerse, Belgium4 aut |
700 | 1 | a Biewenga, Jeikeu Janssen, Beerse, Belgium4 aut |
700 | 1 | a Van Peer, Achielu Janssen, Beerse, Belgium4 aut |
700 | 1 | a Lloyd, Richardu GlaxoSmithKline, Brentford, Middx, England4 aut |
700 | 1 | a Shardlow, Caroleu GlaxoSmithKline, Brentford, Middx, England4 aut |
700 | 1 | a Langguth, Peteru Johannes Gutenberg Univ Mainz, Mainz, Germany4 aut |
700 | 1 | a Mishenzon, Irinau Johannes Gutenberg Univ Mainz, Mainz, Germany4 aut |
700 | 1 | a Nguyen, Mai Anh4 aut |
700 | 1 | a Brown, Jonathanu Bristol Myers Squibb, Uxbridge, Middx, England4 aut |
700 | 1 | a Lennernäs, Hansu Uppsala universitet,Institutionen för farmaci4 aut0 (Swepub:uu)hanslenn |
700 | 1 | a Abrahamsson, Bertilu AstraZeneca, Gothenburg, Sweden4 aut |
710 | 2 | a Univ Manchester, Manchester M13 9PL, Lancs, Englandb AstraZeneca, London, England;Sanofi, Paris, France4 org |
773 | 0 | t European Journal of Pharmaceutical Sciencesd : Elsevier BVg 96, s. 626-642q 96<626-642x 0928-0987x 1879-0720 |
856 | 4 | u https://www.research.manchester.ac.uk/portal/files/46273976/Darwich_2016_IMI_ORBITO_3.pdf |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-361078 |
856 | 4 8 | u https://doi.org/10.1016/j.ejps.2016.09.037 |
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