-
1
-
-
38949088196
-
Metabolism and toxicity of drugs Two decades of progresses in industrial drug metabolism
-
Baille TA. Metabolism and toxicity of drugs. Two decades of progresses in industrial drug metabolism. Chem Res Toxicol 2008;21:129-37
-
(2008)
Chem. Res. Toxicol
, vol.21
, pp. 129-137
-
-
Baille, T.A.1
-
2
-
-
77149134951
-
Proof of concept: A PhRMA position paper with recommendations for best practice
-
Cartwright ME, Cohen S, Fleishaker JC, et al. Proof of concept: a PhRMA position paper with recommendations for best practice. Clin Pharmacol Ther 2010;87(3):278-85
-
(2010)
Clin. Pharmacol. Ther.
, vol.87
, Issue.3
, pp. 278-285
-
-
Cartwright, M.E.1
Cohen, S.2
Fleishaker, J.C.3
-
3
-
-
79958086738
-
Food and drug administrations critical path initiative and innovations in drug development paradigm: Challenges progress and controversies
-
Mahajan R, Gupta K. Food and drug administration's critical path initiative and innovations in drug development paradigm: challenges, progress and controversies. J Pharm Bioallied Sci 2010;2(4):307-13
-
(2010)
J. Pharm. Bioallied Sci.
, vol.2
, Issue.4
, pp. 307-313
-
-
Mahajan, R.1
Gupta, K.2
-
4
-
-
67649209050
-
Discovery DMPK: Changing paradigms in the eighties nineties and noughties
-
Summerfield S, Jeffrey P. Discovery DMPK: changing paradigms in the eighties, nineties and noughties. Expert Opin Drug Discov 2009;4(2):207-18
-
(2009)
Expert Opin. Drug. Discov.
, vol.4
, Issue.2
, pp. 207-218
-
-
Summerfield, S.1
Jeffrey, P.2
-
5
-
-
0029088460
-
Goals design timing and future opportunities for nonclinical drug metabolism studies
-
Miwa GT. Goals, design, timing and future opportunities for nonclinical drug metabolism studies. Toxicol Pathol 1995;23(2):131-5
-
(1995)
Toxicol. Pathol.
, vol.23
, Issue.2
, pp. 131-135
-
-
Miwa, G.T.1
-
6
-
-
0020453266
-
General considerations for studies of the metabolism of drugs and other chemicals
-
Glocklin VC. General considerations for studies of the metabolism of drugs and other chemicals. Drug Metab Rev 1982;13(6):929-39 (Pubitemid 13220532)
-
(1982)
Drug Metabolism Reviews
, vol.13
, Issue.6
, pp. 929-939
-
-
Glocklin, V.C.1
-
7
-
-
84856099204
-
The european agency for the evaluation of medicinal products
-
Note for guidance on Toxicokinetics: A guidance for assessing systemic exposure in toxicology studies CPMP/ICH/384/95 Available from www.ema.europa.eu/ docs/en-GB/document-library/ Scientific-guideline/2009/09/ WC500002770.pdf
-
Note for guidance on Toxicokinetics: a guidance for assessing systemic exposure in toxicology studies CPMP/ICH/384/95 (2009). The European Agency for the Evaluation of Medicinal Products. Human medicines evaluation unit. Available from: www.ema.europa.eu/ docs/en-GB/document-library/ Scientific-guideline/ 2009/09/ WC500002770.pdf
-
(2009)
Human Medicines Evaluation Unit
-
-
-
8
-
-
79960136143
-
Surgical and pharmacological animal models used in drug metabolism and pharmacokinetics
-
Landskroner KA, Hess P, Treiber A. Surgical and pharmacological animal models used in drug metabolism and pharmacokinetics. Xenobiotica 2011;41(8):687-700
-
(2011)
Xenobiotica
, vol.41
, Issue.8
, pp. 687-700
-
-
Landskroner, K.A.1
Hess, P.2
Treiber, A.3
-
9
-
-
67650088429
-
ADDME- Avoiding drug development mistakes early: Central nervous system drug discovery perspective
-
10.1186/1471- 2377-9-S1-S1
-
Tsaioun K, Bottlaender M, Mabondzo A. ADDME- Avoiding drug development mistakes early: central nervous system drug discovery perspective. BMC Neurol 2009;9(S1):doi 10.1186/1471- 2377-9-S1-S1
-
(2009)
BMC Neurol.
, vol.9
, Issue.1
-
-
Tsaioun, K.1
Bottlaender, M.2
Mabondzo, A.3
-
10
-
-
56749183619
-
Toward an improved prediction of human in vivo brain penetration
-
Summerfield SG, Lucas AJ, Porter RA, et al. Toward an improved prediction of human in vivo brain penetration. Xenobiotica 2008;38(12):1518-35
-
(2008)
Xenobiotica
, vol.38
, Issue.12
, pp. 1518-1535
-
-
Summerfield, S.G.1
Lucas, A.J.2
Porter, R.A.3
-
11
-
-
0034955150
-
Pharmacokinetic theory of cassette dosing in drug discovery screening
-
White RE, Manitpisitkul P. Pharmacokinetic theory of cassette dosing in drug discovery setting. Drug Met Dispos. 2001;29(7):957-66 (Pubitemid 32605910)
-
(2001)
Drug Metabolism and Disposition
, vol.29
, Issue.7
, pp. 957-966
-
-
White, R.E.1
Manitpisitkul, P.2
-
12
-
-
79960130501
-
Cassette dosing for pharmacokinetic screening in drug discovery: Comparison of clearance, volume of distribution half-life mean residence time and oral bioavailability obtained by cassette and discrete dosing in rats
-
Nagilla R, Nord M, Mcatee JJ, Jolivette LJ. Cassette dosing for pharmacokinetic screening in drug discovery: comparison of clearance, volume of distribution, half-life, mean residence time and oral bioavailability obtained by cassette and discrete dosing in rats. J Pharm Sci 2011;100(9):3862-74
-
(2011)
J. Pharm. Sci.
, vol.100
, Issue.9
, pp. 3862-3874
-
-
Nagilla, R.1
Nord, M.2
Mcatee, J.J.3
Jolivette, L.J.4
-
14
-
-
84856085280
-
-
Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3 R2 CPMP/ICH/ 286/95 European Agency for the Evaluation of Medicinal Products Available from www.ema.europa.eu/ docs/en-GB/document-library/ Scientific-guideline/2009/09/ WC500002720.pdf
-
Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2) CPMP/ICH/ 286/95 (2009). The European Agency for the Evaluation of Medicinal Products. Human medicines evaluation unit. Available from: www.ema.europa.eu/ docs/en-GB/document-library/ Scientific-guideline/2009/09/ WC500002720.pdf
-
(2009)
Human Medicines Evaluation Unit
-
-
-
15
-
-
78649231563
-
Challenges and solutions to metabolites in safety testing: Impact of the International Conference on Harmonization M31 R2 guidance
-
Yu H, Bischoff D, Tweedie D. Challenges and solutions to metabolites in safety testing: impact of the International Conference on Harmonization M3(R2) guidance. Expert Opin Drug Metab Toxicol 2010;6(12):1539-49
-
(2010)
Expert Opin. Drug. Metab Toxicol
, vol.6
, Issue.12
, pp. 1539-1549
-
-
Yu, H.1
Bischoff, D.2
Tweedie, D.3
-
16
-
-
79960145301
-
From definition to implementation: A cross-industry perspective of past current and future MIST strategies
-
Nedderman ANR, Dear GJ, North S, et al. From definition to implementation: a cross-industry perspective of past, current and future MIST strategies. Xenobiotica 2011;41(8):605-22
-
(2011)
Xenobiotica
, vol.41
, Issue.8
, pp. 605-622
-
-
Nedderman, A.N.R.1
Dear, G.J.2
North, S.3
-
17
-
-
67749104100
-
Metabolites in safety testing: Metabolite identification strategies in discovery and development
-
Nedderman ANR. Metabolites in safety testing: metabolite identification strategies in discovery and development. Biopharm Drug Dispos 2009;30:153-62
-
(2009)
Biopharm Drug. Dispos
, vol.30
, pp. 153-162
-
-
Nedderman, A.N.R.1
-
18
-
-
62249210251
-
Nuclear magnetic resonance spectroscopy as a quantitative tool to determine the concentrations of biologically produced metabolites: Implications in metabolites in safety testing
-
Espina R, Yu L, Wang G, et al. Nuclear magnetic resonance spectroscopy as a quantitative tool to determine the concentrations of biologically produced metabolites: implications in metabolites in safety testing. Chem Res Toxicol 2009;22:299-310
-
(2009)
Chem. Res. Toxicol.
, vol.22
, pp. 299-310
-
-
Espina, R.1
Yu, L.2
Wang, G.3
-
19
-
-
56549113149
-
Evaluation of preparative high performance liquid chromatography and cryoprobe-nuclear magnetic resonance spectroscopy for the early quantitative estimation of drug metabolites in human plasma
-
Dear GJ, Roberts AD, Beaumont C, North SE. Evaluation of preparative high performance liquid chromatography and cryoprobe-nuclear magnetic resonance spectroscopy for the early quantitative estimation of drug metabolites in human plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2008;876:182-90
-
(2008)
J Chromatogr B Analyt Technol Biomed Life Sci.
, vol.876
, pp. 182-190
-
-
Dear, G.J.1
Roberts, A.D.2
Beaumont, C.3
North, S.E.4
-
20
-
-
78649628659
-
A simple liquid chromatography- tandem mass spectrometry method to determine relative plasma exposures of drug metabolites across species for metabolite safety assessments
-
Gao H, Deng S, Obach RS. A simple liquid chromatography- tandem mass spectrometry method to determine relative plasma exposures of drug metabolites across species for metabolite safety assessments. Drug Metab Dispos 2010;38:2147-56
-
(2010)
Drug. Metab. Dispos.
, vol.38
, pp. 2147-2156
-
-
Gao, H.1
Deng, S.2
Obach, R.S.3
-
22
-
-
34247631742
-
The evolving role of drug metabolism in drug discovery and development
-
DOI 10.1007/s11095-006-9217-9
-
Yengi LG, Leung L, Kao J. The evolving role of drug metabolism in drug discovery and development. Pharm Res 2007;24(5); 842-58 (Pubitemid 46675397)
-
(2007)
Pharmaceutical Research
, vol.24
, Issue.5
, pp. 842-858
-
-
Yengi, L.G.1
Leung, L.2
Kao, J.3
-
26
-
-
33947587274
-
Simulation and prediction of in vivo drug metabolism in human populations from in vitro data
-
DOI 10.1038/nrd2173, PII NRD2173
-
Rostami-Hodjegan A, Tucker GT. Simulation and prediction of in vivo drug metabolism in human populations from in vitro data. Nat Rev Drug Discov 2007;6:140-8 (Pubitemid 46745341)
-
(2007)
Nature Reviews Drug Discovery
, vol.6
, Issue.2
, pp. 140-148
-
-
Rostami-Hodjegan, A.1
Tucker, G.T.2
-
27
-
-
21744450105
-
Comprehensive computational assessment of ADME properties using mapping techniques
-
DOI 10.2174/1570163054064666
-
Balakin KV, Ivanenkov YA, Savchuk NP et al. Comprehensive computational assessment of ADME properties using mapping techniques. Curr Drug Discov Technol 2005;2:99-113 (Pubitemid 40943980)
-
(2005)
Current Drug Discovery Technologies
, vol.2
, Issue.2
, pp. 99-113
-
-
Balakin, K.V.1
Ivanenkov, Y.A.2
Savchuk, N.P.3
Ivashchenko, A.A.4
Ekins, S.5
-
28
-
-
79953296456
-
Simulation of human intravenous and oral pharmacokinetics of 21 diverse compounds using physiologically based pharmacokinetic modelling
-
Jones HM, Gardner IB, Collard WT, et al. Simulation of human intravenous and oral pharmacokinetics of 21 diverse compounds using physiologically based pharmacokinetic modelling. Clin Pharmacokinet 2011;50(5):331-47
-
(2011)
Clin. Pharmacokinet
, vol.50
, Issue.5
, pp. 331-347
-
-
Jones, H.M.1
Gardner, I.B.2
Collard, W.T.3
-
29
-
-
84856099203
-
Prediction of pathways of drug metabolism
-
Daly A editor The Biomedical & Life sciences collection Henry Stewards talks Ltd London; Available from http:/ hstalks.com/bio
-
Dickins M. Prediction of pathways of drug metabolism. In:. Daly A, editor. Drug metabolizing enzymes: fundamentals, study methods, recent advances and clinical significance. The Biomedical & Life sciences collection. Henry Stewards talks Ltd, London; 2007. Available from: http:/ hstalks.com/bio
-
(2007)
Drug Metabolizing Enzymes: Fundamentals Study Methods Recent Advances and Clinical Significance
-
-
Dickins, M.1
-
30
-
-
0042161645
-
Whole body pharmacokinetic models
-
DOI 10.2165/00003088-200342100-00002
-
Nestorov I. Whole body pharmacokinetic models. Clin pharmacokinet 2003;42(10):883-908 (Pubitemid 36995260)
-
(2003)
Clinical Pharmacokinetics
, vol.42
, Issue.10
, pp. 883-908
-
-
Nestorov, I.1
-
32
-
-
27744581318
-
Drug tissue distribution: Study methods and therapeutic implications
-
DOI 10.2174/138161205774580679
-
Lanao JM, Fraile MA. Drug tissue distribution: study methods and therapeutic implications. Curr Pharm Des 2005;11:3829-45 (Pubitemid 41632256)
-
(2005)
Current Pharmaceutical Design
, vol.11
, Issue.29
, pp. 3829-3845
-
-
Lanao, J.M.1
Fraile, M.A.2
-
33
-
-
8844242556
-
Methods to assess tissue-specific distribution and metabolism of drugs
-
DOI 10.2174/1389200043335379
-
Langer O, Muller M. Methods to assess tissue-specific distribution and metabolism of drugs. Curr Drug Metab 2004;5:463-81 (Pubitemid 39534493)
-
(2004)
Current Drug Metabolism
, vol.5
, Issue.6
, pp. 463-481
-
-
Langer, O.1
Muller, M.2
-
34
-
-
85008724202
-
The principle of human experimental technique
-
London UK
-
Russell WMS, Burch RL. The principle of human experimental technique. Methuen, London, UK; 1959
-
(1959)
Methuen
-
-
Russell, W.M.S.1
Burch, R.L.2
-
35
-
-
59149106151
-
Toxicity testing in the 21st century bringing the vision to life
-
Andersen ME, Krewski D. Toxicity testing in the 21st century: bringing the vision to life. Toxicol Sci 2009;107(2):324-30
-
(2009)
Toxicol. Sci.
, vol.107
, Issue.2
, pp. 324-330
-
-
Andersen, M.E.1
Krewski, D.2
-
36
-
-
77749283710
-
Replacing reducing and refining animal experiments: Making sound progress but must do better
-
Balls M. Replacing, reducing and refining animal experiments: making sound progress, but must do better. ATLA 2009;37:579-80
-
(2009)
ATLA
, vol.37
, pp. 579-580
-
-
Balls, M.1
-
37
-
-
84856092982
-
Experimental design metabolite profiling and identification and data presentation
-
Zhang D Zhu M Humphreys WG editors Hoboken NJ USA; John Wiley & sons Inc. ADME studies in animals and humans
-
Zhang D, Comezoglu SN. ADME studies in animals and humans. In: Zhang D, Zhu M, Humphreys WG, editors. Experimental design, metabolite profiling and identification, and data presentation in "Drug metabolism in drug design and development". Hoboken, NJ, USA; John Wiley & sons, Inc.; 2008
-
(2008)
Drug Metabolism in Drug Design and Development
-
-
Zhang, D.1
Comezoglu, S.N.2
-
38
-
-
47649088457
-
Unique/major human metabolites: Why, how, and when to test for safety in animals
-
DOI 10.1080/03602530802186561, PII 795102524
-
Luffer-Atlas D. Unique/major metabolites: why, how and when to test for safety in animals. Drug Metab Rev 2008, 40(3):447-63 (Pubitemid 352019965)
-
(2008)
Drug Metabolism Reviews
, vol.40
, Issue.3
, pp. 447-463
-
-
Luffer-Atlas, D.1
-
39
-
-
80051964777
-
Disposition and metabolism of ticagrelor a novel P2Y12 receptor antagonist in mice rats and marmosets
-
Li Y, Landqvist C, Grimm SW. Disposition and metabolism of ticagrelor, a novel P2Y12 receptor antagonist, in mice, rats and marmosets. Drug Metab Dispos 2011;39(9):1555-67
-
(2011)
Drug. Metab. Dispos.
, vol.39
, Issue.9
, pp. 1555-1567
-
-
Li, Y.1
Landqvist, C.2
Grimm, S.W.3
-
40
-
-
38749119372
-
Pharmacokinetics, disposition, and metabolism of bicifadine in the mouse, rat, and monkey
-
DOI 10.1124/dmd.107.017863
-
Musick TJ, Gohdes M, Duffy A, et al. Pharmacokinetics, disposition and metabolism of bicifadine in the mouse, rat and monkey. Drug Metab Dispos 2008;36(2):241-51 (Pubitemid 351185735)
-
(2008)
Drug Metabolism and Disposition
, vol.36
, Issue.2
, pp. 241-251
-
-
Musick, T.J.1
Gohdes, M.2
Duffy, A.3
Erickson, D.A.4
Krieter, P.A.5
-
41
-
-
33847081694
-
What is the objective of the mass balance study A retrospective analysis of data in animal and human excretion studies employing radiolabeled drugs
-
Roffey SJ, Obach RS, Gedge JI, Smith DA. What is the objective of the mass balance study? A retrospective analysis of data in animal and human excretion studies employing radiolabeled drugs. Drug Metab Rev 2007;39:17-43
-
(2007)
Drug. Metab. Rev.
, vol.39
, pp. 17-43
-
-
Roffey, S.J.1
Obach, R.S.2
Gedge, J.I.3
Smith, D.A.4
-
42
-
-
0024625159
-
14C-tiropramide after single intravenous or peroral administration to the rat
-
Setnikar I, Makovec F, Christe R, et al. Metabolism and excretion of 14C-tiropramide after single intravenous or peroral administration to the rat. Arzneimittel-Forshung 1989;39(3); 328-34 (Pubitemid 19078057)
-
(1989)
Arzneimittel-Forschung/Drug Research
, vol.39
, Issue.3
, pp. 328-334
-
-
Setnikar, I.1
Makovec, F.2
Chiste, R.3
Giachetti, C.4
Zanolo, G.5
-
44
-
-
0345491346
-
Pharmacokinetics, metabolism and excretion of an inhibitor of inducible nitric oxide synthase, L-NIL-TA, in dog
-
DOI 10.1080/00498250310001609183
-
Zang JY, Wang YF, Milton MN, et al. Pharmacokinetics, metabolism and excretion of an inhibitor of inducible nitric oxide synthetase, L-NIL-TA, in dog. Xenobiotica 2003;33(11):1159-71 (Pubitemid 37500172)
-
(2003)
Xenobiotica
, vol.33
, Issue.11
, pp. 1159-1171
-
-
Zhang, J.Y.1
Wang, Y.F.2
Milton, M.N.3
Beconi, M.4
Chang, M.5
Yin, D.6
Breau, A.P.7
Paulson, S.K.8
-
45
-
-
10744224396
-
The metabolic disposition of aprepitant, a substance P receptor antagonist, in rats and dogs
-
DOI 10.1124/dmd.32.2.246
-
Huskey SE, Dean BJ, Doss GA, et al. The metabolic disposition of aprepitant, a substance P receptor antagonist, in rats and dogs. Drug Metab Dispos 2004;32(2):246-58 (Pubitemid 38176943)
-
(2004)
Drug Metabolism and Disposition
, vol.32
, Issue.2
, pp. 246-258
-
-
Huskey, S.-E.W.1
Dean, B.J.2
Doss, G.A.3
Wang, Z.4
Hop, C.E.C.A.5
Anari, R.6
Finke, P.E.7
Robichaud, A.J.8
Zhang, M.9
Wang, B.10
Strauss, J.R.11
Cunningham, P.K.12
Feeney, W.P.13
Franklin, R.B.14
Baillie, T.A.15
Chiu, S.-H.L.16
-
46
-
-
77950948600
-
Use of entero-test a novel approach for the noninvasive capture of biliary metabolites in dogs
-
Guiney WJ, Beaumont C, Thomas SR. Use of entero-test, a novel approach for the noninvasive capture of biliary metabolites in dogs. Drug etab Dispos. 2010;38:851-6
-
(2010)
Drug. Etab. Dispos.
, vol.38
, pp. 851-856
-
-
Guiney, W.J.1
Beaumont, C.2
Thomas, S.R.3
-
47
-
-
77957113990
-
Metabolic disposition of casopitant a potent neurokinin-1 receptor antagonist in mice rats and dogs
-
Miraglia L, Pagliarusco P, Bordini E, et al. Metabolic disposition of casopitant, a potent neurokinin-1 receptor antagonist, in mice, rats and dogs. Drug Metab Dispos 2010;38:1876-91
-
(2010)
Drug. Metab. Dispos.
, vol.38
, pp. 1876-1891
-
-
Miraglia, L.1
Pagliarusco, P.2
Bordini, E.3
-
48
-
-
0031892909
-
Quantitative comparison of autoradioluminographic and radiometric tissue distribution studies using carbon-14 labeled xenobiotics
-
Potchoiba MJ, West M, Nocerini MR. Quantitative comparison of autoradioluminographic and radiometric tissue distribution studies using carbon-14 labeled xenobiotics. Drug Metab Dispos. 1998;26:272-7 (Pubitemid 28182405)
-
(1998)
Drug Metabolism and Disposition
, vol.26
, Issue.3
, pp. 272-277
-
-
Potchoiba, M.J.1
West, M.2
Nocerini, M.R.3
-
49
-
-
34447528682
-
Autoradiography: High-resolution molecular imaging in pharmaceutical discovery and development
-
DOI 10.1517/17460441.2.4.503
-
Solon EG. Autoradiography: high resolution molecular imaging in pharmaceutical discovery and development. Expert Opin Drug Discov 2007;2(4):503-14 (Pubitemid 47073075)
-
(2007)
Expert Opinion on Drug Discovery
, vol.2
, Issue.4
, pp. 503-514
-
-
Solon, E.G.1
-
51
-
-
0036783401
-
Whole-body autoradiography in drug discovery
-
DOI 10.2174/1389200023337207
-
Solon EG, Balani SK, Lee FW. Whole body autoradiography in drug discovery. Curr Drug Metab 2002;3:451-62 (Pubitemid 34982179)
-
(2002)
Current Drug Metabolism
, vol.3
, Issue.5
, pp. 451-462
-
-
Solon, E.G.1
Balani, S.K.2
Lee, F.W.3
-
52
-
-
0035527670
-
Quantitative whole-body autoradiography in the pharmaceutical industry - Survey results on study design, methods, and regulatory compliance
-
DOI 10.1016/S1056-8719(02)00161-2, PII S1056871902001612
-
Solon EG, Kraus L. Quantitative whole-body autoradiography in the pharmaceutical industry. Survey results on study design, methods, and regulatory compliance. J Pharmacol Toxicol Methods 2001;46(2):73-81 (Pubitemid 34680996)
-
(2001)
Journal of Pharmacological and Toxicological Methods
, vol.46
, Issue.2
, pp. 73-81
-
-
Solon, E.G.1
Kraus, L.2
-
53
-
-
57349096366
-
Lacteal secretion fetal and maternal tissue distribution of dasatinib in rats
-
He K, Lago MW, Shyu WC, et al. Lacteal secretion, fetal and maternal tissue distribution of dasatinib in rats. Drug Metab Dispos. 2008;36:2564-70
-
(2008)
Drug. Metab. Dispos.
, vol.36
, pp. 2564-2570
-
-
He, K.1
Lago, M.W.2
Shyu, W.C.3
-
54
-
-
20444499704
-
The presence of drug in control samples during toxicokinetic investigations - A Novartis perspective
-
DOI 10.1016/j.yrtph.2005.03.004, PII S0273230005000474
-
Nicholis I, Kolopp M, Pommier F, Scheiwiller M. The presence of drug in control samples during toxicokinetic investigations - A Novartis perspective. Regul Toxicol Pharmacol 2005;42(2):172-8 (Pubitemid 40826562)
-
(2005)
Regulatory Toxicology and Pharmacology
, vol.42
, Issue.2
, pp. 172-178
-
-
Nicholls, I.1
Kolopp, M.2
Pommier, F.3
Scheiwiller, M.4
-
55
-
-
70349399011
-
Identification of interspecies difference in hepatobiliary transporters to improve extrapolation of human biliary secretion
-
Lay Y. Identification of interspecies difference in hepatobiliary transporters to improve extrapolation of human biliary secretion. Expert Opin Drug Metab Toxicol 2009;5(10):1175-87
-
(2009)
Expert Opin. Drug. Metab. Toxicol.
, vol.5
, Issue.10
, pp. 1175-1187
-
-
Lay, Y.1
-
56
-
-
77951205006
-
Biliary excretion in dogs: Evidence for a molecular weight threshold
-
Yang X, Gandhi YA, Morris ME. Biliary excretion in dogs: evidence for a molecular weight threshold. Eur J Pharm Sci 2010;40:33-7
-
(2010)
Eur. J. Pharm. Sci.
, vol.40
, pp. 33-37
-
-
Yang, X.1
Gandhi, Y.A.2
Morris, M.E.3
-
57
-
-
79954626171
-
Biotransformation of diazepam in a clinically relevant flat membrane bioreactor model using primary porcine hepatocytes
-
Maringka M, Giri S, Nieber K, et al. Biotransformation of diazepam in a clinically relevant flat membrane bioreactor model using primary porcine hepatocytes. Fundam Clin Pharmacol 2011;25(3):343-53
-
(2011)
Fundam Clin. Pharmacol.
, vol.25
, Issue.3
, pp. 343-353
-
-
Maringka, M.1
Giri, S.2
Nieber, K.3
-
58
-
-
10744231826
-
New hepatocyte in vitro systems for drug metabolism: Metabolic capacity and recommendations for application in basic research and drug development, standard operation procedures
-
Gebhardt R, Hengstler JG, Muller D, et al. New hepatocyte in vitro systems for drug metabolism: metabolic capacity and recommendations for application in basic research and drug development, standard operation procedures. Drug Metab Rev 2003;35(2-3):145-213 (Pubitemid 37048295)
-
(2003)
Drug Metabolism Reviews
, vol.35
, Issue.2-3
, pp. 145-213
-
-
Gebhardt, R.1
Hengstler, J.G.2
Muller, D.3
Glockner, R.4
Buenning, P.5
Laube, B.6
Schmelzer, E.7
Ullrich, M.8
Utesch, D.9
Hewitt, N.10
Ringel, M.11
Hilz, B.R.12
Bader, A.13
Langsch, A.14
Koose, T.15
Burger, H.-J.16
Maas, J.17
Oesch, F.18
-
59
-
-
62249117708
-
Obtaining exposures of metabolites in preclinical species through plasma pooling and quantitative NMR: Addressing metabolites in safety testing MIST guidance without using radiolabeled compounds and chemically synthesized metabolite standards
-
Vishwanathan K, Babalola K, Espina R, et al. Obtaining exposures of metabolites in preclinical species through plasma pooling and quantitative NMR: addressing metabolites in safety testing (MIST) guidance without using radiolabeled compounds and chemically synthesized metabolite standards. Chem Res Toxicol 2009;22(2):311-22
-
(2009)
Chem. Res. Toxicol.
, vol.22
, Issue.2
, pp. 311-322
-
-
Vishwanathan, K.1
Babalola, K.2
Espina, R.3
-
60
-
-
84856107711
-
Note for guidance on dose selection for carcinogenicity studies of pharmaceuticals
-
ICH Topic S1C R2 Available from
-
ICH Topic S1C(R2). Note for guidance on dose selection for carcinogenicity studies of pharmaceuticals. EMEA/ CHMP/ICH/383/1995. 2008. Available from: http://www.ema.europa.eu/docs/ en-GB/document-library/ Scientific-guideline/2009/09/ WC500002768.pdf
-
(2008)
EMEA/ CHMP/ICH/383/ 1995
-
-
-
61
-
-
0023273626
-
Species specificity in the metabolism of nabilone. Relationship between toxicity and metabolic routes
-
Sullivan HR, Hanasomo GK, Miller WM, Wood PG. Species specificity in the metabolism of nabilone. Relationship between toxicity and metabolic routes. Xenobiotica 1987;17(4):459-68 (Pubitemid 17063574)
-
(1987)
Xenobiotica
, vol.17
, Issue.4
, pp. 459-468
-
-
Sullivan, H.R.1
Hanasono, G.K.2
Miller, W.M.3
Wood, P.G.4
-
62
-
-
0032461872
-
Binding of drugs to eye melanin is not predictive of ocular toxicity
-
DOI 10.1006/rtph.1998.1243
-
Leblanc B, Jezequel S, Davies T et al. Binding of drugs to eye melanin is not predictive of ocular toxicity. Regul Toxicol Pharmacol 1998;28:124-32 (Pubitemid 29076778)
-
(1998)
Regulatory Toxicology and Pharmacology
, vol.28
, Issue.2
, pp. 124-132
-
-
Leblanc, B.1
Jezequel, S.2
Davies, T.3
Hanton, G.4
Taradach, C.5
-
63
-
-
70349527779
-
-
Guidance for industry Available from fda. FDA/Center for Drug Evaluation and Research
-
Guidance for industry. Photosafety testing. FDA/Center for Drug Evaluation and Research. 2003. Available from: http://www.fda.gov/downloads/ Drugs/GuidanceCompliance RegulatoryInformation/ Guidances/ucm079252.pdf
-
(2003)
Photosafety testing
-
-
-
64
-
-
0025002026
-
Physicochemical factors associated with binding and retention of compounds in ocular melanin of rats: Correlations using data from whole-body autoradiography and molecular modeling for multiple linear regression analyses
-
Zane PA, Brindle SD, Gause DO, et al. Physicochemical factors associated with binding and retention of compounds in ocular melanin of rats; correlation using data from whole-body autoradiography and molecular modeling for multiple linear regression analyses. Pharm Res 1990;7:935-41 (Pubitemid 20349766)
-
(1990)
Pharmaceutical Research
, vol.7
, Issue.9
, pp. 935-941
-
-
Zane, P.A.1
Brindle, S.D.2
Gause, D.O.3
O'Buck, A.J.4
Raghavan, P.R.5
Tripp, S.L.6
-
65
-
-
0028237535
-
Are routine tissue distribution studies justifiable for approval of human drugs?
-
Monro AM. Are routine tissue distribution studies justifiable for approval of human drugs? Drug Metab Dispos 1994;22(3):341-2 (Pubitemid 24158529)
-
(1994)
Drug Metabolism and Disposition
, vol.22
, Issue.3
, pp. 341-342
-
-
Monro, A.M.1
-
66
-
-
2542465772
-
Myopathy related to administration of a cationic amphiphilic drug and the use of multidose drug distribution analysis to predict its occurrence
-
DOI 10.1080/01926230490431763
-
Vonderfect SL, Stone ML, Eversole RR, et al. Myopathy related to administration of a cationic amphiphilic drug and the use of multidose drug distribution analysis to predict its occurrence. Toxicol Pathol 2004, 32:318-25 (Pubitemid 38692002)
-
(2004)
Toxicologic Pathology
, vol.32
, Issue.3
, pp. 318-325
-
-
Vonderfecht, S.L.1
Stone, M.L.2
Eversole, R.R.3
Yancey, M.F.4
Schuette, M.R.5
Duncan, B.A.6
Ware, J.A.7
-
67
-
-
0035894049
-
Analysis of two matrix metalloproteinase inhibitors and their metabolites for induction of phospholipidosis in rat and human hepatocytes
-
DOI 10.1016/S0006-2952(01)00823-1, PII S0006295201008231
-
Gum RJ, Hickman D, Fagerland JA, et al. Analysis of two matrix metalloproteinase inhibitors and their metabolites for induction of phospholipidosis in rat and human hepatocytes. Biochem Pharmacol 2001;62:1661-73 (Pubitemid 34033653)
-
(2001)
Biochemical Pharmacology
, vol.62
, Issue.12
, pp. 1661-1673
-
-
Gum, R.J.1
Hickman, D.2
Fagerland, J.A.3
Heindel, M.A.4
Gagne, G.D.5
Schmidt, J.M.6
Michaelides, M.R.7
Davidsen, S.K.8
Ulrich, R.G.9
-
68
-
-
79952459611
-
Accelerator mass spectrometry - Enabled studies: Current status and future prospects
-
Arjomand A. Accelerator mass spectrometry- enabled studies: current status and future prospects. Bioanalysis 2010;2(3):519-41
-
(2010)
Bioanalysis
, vol.2
, Issue.3
, pp. 519-541
-
-
Arjomand, A.1
-
69
-
-
79952495863
-
Addressing metabolite safety during first-in-man studies using 14C-labeled drug and accelerator mass spectrometry
-
Lappin G, Seymour M. Addressing metabolite safety during first-in-man studies using 14C-labeled drug and accelerator mass spectrometry. Bioanalysis 2010;2(7):1315-24
-
(2010)
Bioanalysis
, vol.2
, Issue.7
, pp. 1315-1324
-
-
Lappin, G.1
Seymour, M.2
-
70
-
-
63649092684
-
Dried Blood Spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: Considerations for the validation of a quantitative bioanalytical method
-
Spooner N, Lad R, Barfield M. Dried Blood Spots as a sample collection technique for the determination of pharmacokinetics in clinical studies: considerations for the validation of a quantitative bioanalytical method. Anal Chem 2009;81:1557-63
-
(2009)
Anal. Chem.
, vol.81
, pp. 1557-1563
-
-
Spooner, N.1
Lad, R.2
Barfield, M.3
-
71
-
-
77953689331
-
Facilitating pharmacokinetic studies in children: A new use of dried blood spots
-
Patel P, Mulla H, Tanna S. Facilitating pharmacokinetic studies in children: a new use of dried blood spots. Arch Dis Child 2010;95:484-7
-
(2010)
Arch. Dis. Child.
, vol.95
, pp. 484-487
-
-
Patel, P.1
Mulla, H.2
Tanna, S.3
-
72
-
-
84856114338
-
Metabolites in safety testing: Issues and approaches to the safety evaluation of human metabolites in a drug that is extensively metabolized
-
Griffini P, James AD, Roberts AD, Pellegatti M. Metabolites in safety testing: issues and approaches to the safety evaluation of human metabolites in a drug that is extensively metabolized. J Drug Metab Toxicol 2010;1:102
-
(2010)
J. Drug. Metab. Toxicol.
, vol.1
, pp. 102
-
-
Griffini, P.1
James, A.D.2
Roberts, A.D.3
Pellegatti, M.4
-
73
-
-
77949882361
-
Relations between toxicity and altered tissue distribution and urinary excretion of nicotine cotinine and hydroxycotinine after chronic oral administration of nicotine in rats
-
Kim KY, Lee YJ, Chung BC, et al. Relations between toxicity and altered tissue distribution and urinary excretion of nicotine, cotinine and hydroxycotinine after chronic oral administration of nicotine in rats. Drug Chem Toxicol 2010;33(2):166-72
-
(2010)
Drug. Chem. Toxicol.
, vol.33
, Issue.2
, pp. 166-172
-
-
Kim, K.Y.1
Lee, Y.J.2
Chung, B.C.3
-
74
-
-
79251483847
-
Tissue distribution and characterisation of drug related material in rats and dogs after repeat oral administration of casopitant
-
Pagliarusco S, Martinucci S, Bordin E, et al. Tissue distribution and characterisation of drug related material in rats and dogs after repeat oral administration of casopitant. Drug Metab Dispos. 2011;39(2):283-93
-
(2011)
Drug. Metab. Dispos.
, vol.39
, Issue.2
, pp. 283-293
-
-
Pagliarusco, S.1
Martinucci, S.2
Bordin, E.3
-
75
-
-
82955193812
-
Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: Are they still necessary
-
Obach RS, Nedderman AN, Smith DA. Radiolabelled mass-balance excretion and metabolism studies in laboratory animals: are they still necessary? Xenobiotica 2012;42(1):46-56
-
(2012)
Xenobiotica
, vol.42
, Issue.1
, pp. 46-56
-
-
Obach, R.S.1
Nedderman, A.N.2
Smith, D.A.3
|