TY - JOUR AU - Peter, G. PY - 1977 DA - 1977// TI - Welling. Influence of food and diet on gastrointestinal drug absorption JO - J Pharmacokinet Biopharm VL - 5 UR - https://doi.org/10.1007/BF01061694 DO - 10.1007/BF01061694 ID - Peter1977 ER - TY - JOUR AU - Pater, G. PY - 1989 DA - 1989// TI - Welling.Effect of food on drug absorption JO - Pharmac Ther VL - 43 UR - https://doi.org/10.1016/0163-7258(89)90019-3 DO - 10.1016/0163-7258(89)90019-3 ID - Pater1989 ER - TY - BOOK AU - Waterbeemd, H. AU - Testa, B. AU - Mannhold, R. AU - Kubinyi, H. AU - Folkers, G. PY - 2009 DA - 2009// TI - Drug bioavailability: estimation of solubility, permeability, absorption and bioavailability PB - Co. CY - Weinheim ID - Waterbeemd2009 ER - TY - JOUR AU - Devriese, L. A. AU - Koch, K. M. AU - Mergui-Roelvink, M. AU - Matthys, G. M. AU - Ma, W. W. AU - Robidoux, A. AU - Stephenson, J. J. AU - Chu, Q. S. AU - Orford, K. W. AU - Cartee, L. AU - Botbyl, J. AU - Arya, N. AU - Schellens, J. H. PY - 2014 DA - 2014// TI - Effects of low-fat and high-fat meals on steady-state pharmacokinetics of lapatinib in patients with advanced solid tumours JO - Investig New Drugs VL - 32 UR - https://doi.org/10.1007/s10637-013-0055-4 DO - 10.1007/s10637-013-0055-4 ID - Devriese2014 ER - TY - JOUR AU - Amidon, G. L. AU - Lennernäs, H. AU - Shah, V. P. AU - Crison, J. R. PY - 1995 DA - 1995// TI - A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drugproduct dissolution and in vivo bioavailability JO - Pharm Res VL - 12 UR - https://doi.org/10.1023/A:1016212804288 DO - 10.1023/A:1016212804288 ID - Amidon1995 ER - TY - JOUR AU - Fleisher, D. AU - Li, C. AU - Zhou, Y. AU - Pao, L. H. AU - Karim, A. PY - 1999 DA - 1999// TI - Drug, meal and formulation interactions influencing drug absorption after oral administration. Clinical implications JO - Clin Pharmacokinet VL - 36 UR - https://doi.org/10.2165/00003088-199936030-00004 DO - 10.2165/00003088-199936030-00004 ID - Fleisher1999 ER - TY - JOUR AU - Wu, C. Y. AU - Benet, L. Z. PY - 2005 DA - 2005// TI - Predicting drug disposition via application of BCS: transport/absorption/elimination interplay and development of a biopharmaceutics drug disposition classification system JO - Pharm Res VL - 22 UR - https://doi.org/10.1007/s11095-004-9004-4 DO - 10.1007/s11095-004-9004-4 ID - Wu2005 ER - TY - JOUR AU - Gu, C. H. AU - Li, H. AU - Levons, J. AU - Lentz, K. AU - Gandhi, R. B. AU - Raghavan, K. AU - Smith, R. L. PY - 2007 DA - 2007// TI - Predicting effect of food on extent of drug absorption based on physicochemical properties JO - Pharm Res VL - 24 UR - https://doi.org/10.1007/s11095-007-9236-1 DO - 10.1007/s11095-007-9236-1 ID - Gu2007 ER - TY - STD TI - List of Approved Products. PMDA,Tokyo, 2019. https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html. Accessed 3 Sept 2019. UR - https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html.%20Accessed%203%20Sept%202019 ID - ref9 ER - TY - JOUR AU - Parsad, S. AU - Ratain, M. J. PY - 2017 DA - 2017// TI - Food effect studies for oncology drug products JO - Clin Pharmacol Ther VL - 101 UR - https://doi.org/10.1002/cpt.610 DO - 10.1002/cpt.610 ID - Parsad2017 ER - TY - BOOK AU - Urabe, A. AU - Shimada, K. AU - Kawai, S. PY - 2018 DA - 2018// TI - Today’s drug therapy in 2018 PB - Nankodo Co. Ltd CY - Tokyo ID - Urabe2018 ER - TY - JOUR AU - Singh, B. N. AU - Malhotra, B. K. PY - 2004 DA - 2004// TI - Effects of food on the clinical pharmacokinetics of anticancer agents JO - Clin Pharmacokinet VL - 43 UR - https://doi.org/10.2165/00003088-200443150-00005 DO - 10.2165/00003088-200443150-00005 ID - Singh2004 ER - TY - JOUR AU - Jain, R. K. AU - Brar, S. S. AU - Lesko, L. J. PY - 2010 DA - 2010// TI - Food and Oral Antineoplastics: more than meets the eye JO - Clin Cancer Res VL - 16 UR - https://doi.org/10.1158/1078-0432.CCR-10-1857 DO - 10.1158/1078-0432.CCR-10-1857 ID - Jain2010 ER - TY - JOUR AU - Ruggiero, A. AU - Cefalo, M. G. AU - Coccia, P. AU - Mastrangelo, S. AU - Maurizi, P. AU - Riccardi, R. PY - 2012 DA - 2012// TI - The role of diet on the clinical pharmacology of oral antineoplastic agents JO - Eur J Clin Pharmacol VL - 68 UR - https://doi.org/10.1007/s00228-011-1102-8 DO - 10.1007/s00228-011-1102-8 ID - Ruggiero2012 ER - TY - STD TI - Drug inserts, interview forms, and examination reports of each oral antineoplastic drugs. [in Japanese] http://www.pmda.go.jp/PmdaSearch/iyakuSearch/ Accessed 3 Sept 2019. UR - http://www.pmda.go.jp/PmdaSearch/iyakuSearch/ ID - ref15 ER - TY - STD TI - Guideline for bioequivalence studies of generic products. PMDA,Tokyo, 2012 [in Japanese] https://www.pmda.go.jp/files/000160026.pdf Accessed 3 Sept 2019. UR - https://www.pmda.go.jp/files/000160026.pdf ID - ref16 ER - TY - JOUR AU - Jantratid, E. AU - Janssen, N. AU - Reppas, C. AU - Dressman, J. B. PY - 2008 DA - 2008// TI - Dissolution media simulating conditions in the proximal human gastrointestinal tract: an update JO - Pharm Res VL - 25 UR - https://doi.org/10.1007/s11095-008-9569-4 DO - 10.1007/s11095-008-9569-4 ID - Jantratid2008 ER - TY - JOUR AU - Gamsiz, E. D. AU - Ashtikar, M. AU - Crison, J. AU - Woltosz, W. AU - Bolger, M. B. AU - Carrier, R. L. PY - 2010 DA - 2010// TI - Predicting the effect of fed-state intestinal contents on drug dissolution JO - Pharm Res VL - 27 UR - https://doi.org/10.1007/s11095-010-0264-x DO - 10.1007/s11095-010-0264-x ID - Gamsiz2010 ER - TY - JOUR AU - Charman, W. N. AU - Porter, C. J. AU - Mithani, S. AU - Dressman, J. B. PY - 1997 DA - 1997// TI - Physiochemical and physiological mechanisms for the effects of food on drug absorption: the role of lipids and pH JO - J Pharm Sci VL - 86 UR - https://doi.org/10.1021/js960085v DO - 10.1021/js960085v ID - Charman1997 ER - TY - JOUR AU - Widmer, N. AU - Bardin, C. AU - Chatelut, E. AU - Paci, A. AU - Beijnen, J. AU - Levêque, D. AU - Veal, G. AU - Astier, A. PY - 2014 DA - 2014// TI - Review of therapeutic drug monitoring of anticancer drugs part two--targeted therapies JO - Eur J Cancer VL - 50 UR - https://doi.org/10.1016/j.ejca.2014.04.015 DO - 10.1016/j.ejca.2014.04.015 ID - Widmer2014 ER - TY - JOUR AU - Mithani, S. D. AU - Bakatselou, V. AU - TenHoor, C. N. AU - Dressman, J. B. PY - 1996 DA - 1996// TI - Estimation of the increase in solubility of drugs as a function of bile salt concentration JO - Pharm Res VL - 13 UR - https://doi.org/10.1023/A:1016062224568 DO - 10.1023/A:1016062224568 ID - Mithani1996 ER - TY - JOUR AU - Lipinski, C. A. AU - Lombardo, F. AU - Dominy, B. W. AU - Feeney, P. J. PY - 2001 DA - 2001// TI - Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings JO - Adv Drug Deliv Rev VL - 46 UR - https://doi.org/10.1016/S0169-409X(00)00129-0 DO - 10.1016/S0169-409X(00)00129-0 ID - Lipinski2001 ER - TY - JOUR AU - Winiwarter, S. AU - Bonham, N. M. AU - Ax, F. AU - Hallberg, A. AU - Lennernäs, H. AU - Karlén, A. PY - 1998 DA - 1998// TI - Correlation of human jejunal permeability (in vivo) of drugs with experimentally and theoretically.Derived parameters. A multivariate data analysis approach JO - J Med Chem VL - 41 UR - https://doi.org/10.1021/jm9810102 DO - 10.1021/jm9810102 ID - Winiwarter1998 ER - TY - JOUR AU - Artursson, P. AU - Karlsson, J. PY - 1991 DA - 1991// TI - Correlation between oral drug absorption in humans and apparent drug permeability coefficients in human intestinal epithelial (Caco-2) cells JO - Biochem Biophys Res Commun VL - 175 UR - https://doi.org/10.1016/0006-291X(91)91647-U DO - 10.1016/0006-291X(91)91647-U ID - Artursson1991 ER - TY - JOUR AU - Takagi, T. AU - Ramachandran, C. AU - Bermejo, M. AU - Yamashita, S. AU - Yu, L. X. AU - Amidon, G. L. PY - 2006 DA - 2006// TI - A provisional biopharmaceutical classification of the top 200 oral drug products in the United States, Great Britain, Spain, and Japan JO - Mol Pharm VL - 3 UR - https://doi.org/10.1021/mp0600182 DO - 10.1021/mp0600182 ID - Takagi2006 ER - TY - STD TI - ICH harmonised guideline Biopharmaceutics Classification System-Based Biowaivers M9, Draft version Endorsed on 7 June 2018, https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M9/M9EWG_DraftGuideline_Step2_2018_0606.pdf. UR - https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M9/M9EWG_DraftGuideline_Step2_2018_0606.pdf ID - ref26 ER - TY - JOUR AU - Heimbach, T. AU - Xia, B. AU - Lin, T. H. AU - He, H. PY - 2013 DA - 2013// TI - Case studies for practical food effect assessments across BCS/BDDCS class compounds using in silico, in vitro, and preclinical in vivo data JO - AAPS J VL - 15 UR - https://doi.org/10.1208/s12248-012-9419-5 DO - 10.1208/s12248-012-9419-5 ID - Heimbach2013 ER -