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WFRF:(Szeto Ke X.)
 

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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00007705naa a2201033 4500
001oai:DiVA.org:uu-361078
003SwePub
008180920s2017 | |||||||||||000 ||eng|
0247 a https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-3610782 URI
0247 a https://doi.org/10.1016/j.ejps.2016.09.0372 DOI
040 a (SwePub)uu
041 a engb eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Darwich, Adam S.u Univ Manchester, Manchester M13 9PL, Lancs, England4 aut
2451 0a 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 1b 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 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 Margolskee, Alisonu Univ Manchester, Manchester M13 9PL, Lancs, England4 aut
7001 a Pepin, Xavieru AstraZeneca, London, England;Sanofi, Paris, France4 aut
7001 a Aarons, Leonu Univ Manchester, Manchester M13 9PL, Lancs, England4 aut
7001 a Galetin, Aleksandrau Univ Manchester, Manchester M13 9PL, Lancs, England4 aut
7001 a Rostami-Hodjegan, Aminu Univ Manchester, Manchester M13 9PL, Lancs, England;Simcyp Ltd, Sheffield, S Yorkshire, England4 aut
7001 a Carlert, Sarau AstraZeneca, Gothenburg, Sweden4 aut
7001 a Hammarberg, Mariau AstraZeneca, Gothenburg, Sweden4 aut
7001 a Hilgendorf, Constanzeu AstraZeneca, Gothenburg, Sweden4 aut
7001 a Johansson, Pernillau AstraZeneca, Gothenburg, Sweden4 aut
7001 a Karlsson, Evau AstraZeneca, Gothenburg, Sweden4 aut
7001 a Murphy, Donalu AstraZeneca, London, England4 aut
7001 a Tannergren, Christeru AstraZeneca, Gothenburg, Sweden4 aut
7001 a Thorn, Helenau AstraZeneca, Gothenburg, Sweden4 aut
7001 a Yasin, Mohammedu AstraZeneca, London, England4 aut
7001 a Mazuir, Florentu Sanofi, Paris, France4 aut
7001 a Nicolas, Olivieru Sanofi, Paris, France4 aut
7001 a Ramusovic, Sergeju Sanofi, Frankfurt, Germany4 aut
7001 a Xu, Christineu Sanofi, Bridgewater, NJ USA4 aut
7001 a Pathak, Shriram M.u Simcyp Ltd, Sheffield, S Yorkshire, England4 aut
7001 a Korjamo, Timou Orion Pharma, Espoo, Finland4 aut
7001 a Laru, Johannau Orion Pharma, Espoo, Finland;AstraZeneca, London, England4 aut
7001 a Malkki, Jussiu Orion Pharma, Espoo, Finland4 aut
7001 a Pappinen, Sariu Orion Pharma, Espoo, Finland4 aut
7001 a Tuunainen, Johannau Orion Pharma, Espoo, Finland4 aut
7001 a Dressman, Jenniferu Goethe Univ Frankfurt Am Main, Frankfurt, Germany4 aut
7001 a Hansmann, Simoneu Goethe Univ Frankfurt Am Main, Frankfurt, Germany4 aut
7001 a Kostewicz, Edmundu Goethe Univ Frankfurt Am Main, Frankfurt, Germany4 aut
7001 a He, Handanu Novartis, New York, NY USA4 aut
7001 a Heimbach, Tychou Novartis, New York, NY USA4 aut
7001 a Wu, Fanu Novartis, New York, NY USA4 aut
7001 a Hoft, Carolinu AbbVie, Wiesbaden, Germany4 aut
7001 a Pang, Yanu AbbVie, Wiesbaden, Germany4 aut
7001 a Bolger, Michael B.u Simulat Plus Inc, Lancaster, CA USA4 aut
7001 a Huehn, Evau Simulat Plus Inc, Lancaster, CA USA4 aut
7001 a Lukacova, Vierau Simulat Plus Inc, Lancaster, CA USA4 aut
7001 a Mullin, James M.u Simulat Plus Inc, Lancaster, CA USA4 aut
7001 a Szeto, Ke X.u Simulat Plus Inc, Lancaster, CA USA4 aut
7001 a Costales, Chesteru Pfizer, New York, NY USA4 aut
7001 a Lin, Jianu Pfizer, New York, NY USA4 aut
7001 a McAllister, Marku Pfizer, Tadworth, Middx, England4 aut
7001 a Modi, Swetau Pfizer, New York, NY USA4 aut
7001 a Rotter, Charlesu Pfizer, New York, NY USA4 aut
7001 a Varma, Manthenau Pfizer, Tadworth, Middx, England4 aut
7001 a Wong, Meiu Pfizer, Tadworth, Middx, England4 aut
7001 a Mitra, Amitavau Merck Sharp & Dohme Ltd, Hoddesdon, Herts, England4 aut
7001 a Bevernage, Janu Janssen, Beerse, Belgium4 aut
7001 a Biewenga, Jeikeu Janssen, Beerse, Belgium4 aut
7001 a Van Peer, Achielu Janssen, Beerse, Belgium4 aut
7001 a Lloyd, Richardu GlaxoSmithKline, Brentford, Middx, England4 aut
7001 a Shardlow, Caroleu GlaxoSmithKline, Brentford, Middx, England4 aut
7001 a Langguth, Peteru Johannes Gutenberg Univ Mainz, Mainz, Germany4 aut
7001 a Mishenzon, Irinau Johannes Gutenberg Univ Mainz, Mainz, Germany4 aut
7001 a Nguyen, Mai Anh4 aut
7001 a Brown, Jonathanu Bristol Myers Squibb, Uxbridge, Middx, England4 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. 626-642q 96<626-642x 0928-0987x 1879-0720
8564 u https://www.research.manchester.ac.uk/portal/files/46273976/Darwich_2016_IMI_ORBITO_3.pdf
8564 8u https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-361078
8564 8u https://doi.org/10.1016/j.ejps.2016.09.037

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