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Volumn 100, Issue 10, 2011, Pages 4111-4126

PhRMA CPCDC initiative on predictive models of human pharmacokinetics, part 4: Prediction of plasma concentration-time profiles in human from in vivo preclinical data by using the Wajima approach

(17)  Vuppugalla, Ragini a   Marathe, Punit a   He, Handan b   Jones, Rhys D O c   Yates, James W T c   Jones, Hannah M d   Gibson, Christopher R e   Chien, Jenny Y f   Ring, Barbara J f   Adkison, Kimberly K g   Ku, M Sherry h   Fischer, Volker i   Dutta, Sandeep i   Sinha, Vikash K j   Björnsson, Thorir k   Lavé, Thierry l   Poulin, Patrick m  


Author keywords

Absorption; Allometry; Clearance; Computational ADME; Disposition; Distribution; First time in human; PBPK; Pharmacokinetics; QSAR

Indexed keywords

ALLOMETRY; ANIMAL EXPERIMENT; AREA UNDER THE CURVE; ARTICLE; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; HUMAN; IN VIVO STUDY; MAXIMUM PLASMA CONCENTRATION; MOUSE; NONHUMAN; PLASMA CONCENTRATION-TIME CURVE; QUANTITATIVE STRUCTURE ACTIVITY RELATION; RAT; SIMULATION; STEADY STATE; TIME TO MAXIMUM PLASMA CONCENTRATION; ACCESS TO INFORMATION; ANIMAL; BIOAVAILABILITY; BIOLOGICAL MODEL; BLOOD; COMPARATIVE STUDY; COMPUTER SIMULATION; COOPERATION; DOG; DRUG DATABASE; DRUG DEVELOPMENT; DRUG SCREENING; EVALUATION STUDY; GASTROINTESTINAL ABSORPTION; INTERDISCIPLINARY COMMUNICATION; INTRAVENOUS DRUG ADMINISTRATION; METABOLIC CLEARANCE RATE; METABOLISM; ORAL DRUG ADMINISTRATION; PHARMACOKINETICS; PROCEDURES; PROGRAM DEVELOPMENT; PROGRAM EVALUATION; REPRODUCIBILITY; SPECIES DIFFERENCE; STATISTICAL MODEL;

EID: 80052258840     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22551     Document Type: Article
Times cited : (51)

References (29)
  • 1
    • 35648945837 scopus 로고    scopus 로고
    • On the anticipation of the human dose in First in man trials from preclinical and prior clinical information in early drug development
    • Lowe PJ, Hijazi Y, Luttringer O, Yin H, Sarangapani R, Howard D. 2007. On the anticipation of the human dose in First in man trials from preclinical and prior clinical information in early drug development. Xenobiotica 37:1331-1354.
    • (2007) Xenobiotica , vol.37 , pp. 1331-1354
    • Lowe, P.J.1    Hijazi, Y.2    Luttringer, O.3    Yin, H.4    Sarangapani, R.5    Howard, D.6
  • 2
    • 43349093221 scopus 로고    scopus 로고
    • Projection of exposure and efficacious dose prior to first in human studies: How successful have we been
    • Huang C, Zheng M, Yang Z, Rodrigues AD, Marathe P. 2008. Projection of exposure and efficacious dose prior to first in human studies: How successful have we been? Pharm Res 25;713-726.
    • (2008) Pharm Res , vol.25 , pp. 713-726
    • Huang, C.1    Zheng, M.2    Yang, Z.3    Rodrigues, A.D.4    Marathe, P.5
  • 3
    • 63149182785 scopus 로고    scopus 로고
    • Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: Strategic considerations
    • Gabrielsson J, Dolgos H, Gillberg PG, Bredberg U, Benthem B, Duker G. 2009. Early integration of pharmacokinetic and dynamic reasoning is essential for optimal development of lead compounds: Strategic considerations. Drug Discov Today 14;358-372.
    • (2009) Drug Discov Today , vol.14 , pp. 358-372
    • Gabrielsson, J.1    Dolgos, H.2    Gillberg, P.G.3    Bredberg, U.4    Benthem, B.5    Duker, G.6
  • 5
    • 33747154776 scopus 로고    scopus 로고
    • Prediction of human drug clearance from animal data: Application of the rule of exponents and 'fu Corrected Intercept Method' (FCIM)
    • Mahmood I. 2006. Prediction of human drug clearance from animal data: Application of the rule of exponents and 'fu Corrected Intercept Method' (FCIM). J Pharm Sci 95:1810-1821.
    • (2006) J Pharm Sci , vol.95 , pp. 1810-1821
    • Mahmood, I.1
  • 6
    • 58749116164 scopus 로고    scopus 로고
    • Prediction of human oral pharmacokinetics using nonclinical data: Examples involving four proprietary compounds
    • Fura A, Vyas V, Humphreys W, Chimalokonda A, Rodrigues D. 2008. Prediction of human oral pharmacokinetics using nonclinical data: Examples involving four proprietary compounds. Biopharm Drug Dispos 29:455-468.
    • (2008) Biopharm Drug Dispos , vol.29 , pp. 455-468
    • Fura, A.1    Vyas, V.2    Humphreys, W.3    Chimalokonda, A.4    Rodrigues, D.5
  • 7
    • 0014763674 scopus 로고
    • Interspecies correlation of plasma concentration history of methotrexate (NSC740)
    • Dedrick R, Bischoff KB, Zaharko DS. 1970. Interspecies correlation of plasma concentration history of methotrexate (NSC740). Cancer Chemother Rep 54:95-101.
    • (1970) Cancer Chemother Rep , vol.54 , pp. 95-101
    • Dedrick, R.1    Bischoff, K.B.2    Zaharko, D.S.3
  • 8
    • 34748925493 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetics using Physiologically based modeling: A retrospective analysis of 26 clinically tested drugs
    • DeBuck SS, Sinha VK, Fenu LA, Nijsen MJ, Mackie CE, Gilissen RA. 2007. Prediction of human pharmacokinetics using Physiologically based modeling: A retrospective analysis of 26 clinically tested drugs. Drug Metab Dispos 35:1766-1780.
    • (2007) Drug Metab Dispos , vol.35 , pp. 1766-1780
    • DeBuck, S.S.1    Sinha, V.K.2    Fenu, L.A.3    Nijsen, M.J.4    Mackie, C.E.5    Gilissen, R.A.6
  • 9
    • 33845467297 scopus 로고    scopus 로고
    • Predicting pharmacokinetic food effects using biorelevant solubility media and physiologically based modeling
    • Jones HM, Parrott N, Ohlenbusch G, Lave T. 2006. Predicting pharmacokinetic food effects using biorelevant solubility media and physiologically based modeling. Clin Pharmacokinet 45:1213-1226.
    • (2006) Clin Pharmacokinet , vol.45 , pp. 1213-1226
    • Jones, H.M.1    Parrott, N.2    Ohlenbusch, G.3    Lave, T.4
  • 10
    • 0035478779 scopus 로고    scopus 로고
    • Predicting the impact of physiological and biochemical processes on oral drug bioavailability
    • Agoram B, Woltosz WS, Bolger MB. 2001. Predicting the impact of physiological and biochemical processes on oral drug bioavailability. Adv Drug Deliv Rev 50 Suppl 1:S41-S67.
    • (2001) Adv Drug Deliv Rev , vol.50 , Issue.SUPPL. 1
    • Agoram, B.1    Woltosz, W.S.2    Bolger, M.B.3
  • 13
    • 3042648079 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetic profile in animal scale up based on normalizing time course profiles
    • Wajima T, Yano Y, Fukumura K, Oguma T. 2004. Prediction of human pharmacokinetic profile in animal scale up based on normalizing time course profiles. J Pharm Sci 93:1890-1900.
    • (2004) J Pharm Sci , vol.93 , pp. 1890-1900
    • Wajima, T.1    Yano, Y.2    Fukumura, K.3    Oguma, T.4
  • 14
    • 36849066994 scopus 로고    scopus 로고
    • Pharmacokinetic prediction for intravenous betalactam antibiotics in pediatric patients.
    • Shimamura K, Wajima T, Yano Y. 2007. Pharmacokinetic prediction for intravenous betalactam antibiotics in pediatric patients. J Pharm Sci 96:3125-3139.
    • (2007) J Pharm Sci , vol.96 , pp. 3125-3139
    • Shimamura, K.1    Wajima, T.2    Yano, Y.3
  • 18
    • 23944515735 scopus 로고    scopus 로고
    • A novel model for prediction of human drug clearance by allometric scaling
    • Tang H, Mayersohn M. 2005. A novel model for prediction of human drug clearance by allometric scaling. Drug Metab Dispos 33:1297-1303.
    • (2005) Drug Metab Dispos , vol.33 , pp. 1297-1303
    • Tang, H.1    Mayersohn, M.2
  • 19
    • 0036892637 scopus 로고    scopus 로고
    • Prediction of human clearance from animal data and molecular structural parameters using multivariate regression analysis
    • Wajima T, Fukumura K, Yano Y, Oguma T. 2002. Prediction of human clearance from animal data and molecular structural parameters using multivariate regression analysis. J Pharm Sci 91:2489-2499.
    • (2002) J Pharm Sci , vol.91 , pp. 2489-2499
    • Wajima, T.1    Fukumura, K.2    Yano, Y.3    Oguma, T.4
  • 20
    • 0018668570 scopus 로고
    • Effect of altered plasma protein binding on apparent volume of distribution
    • Øie S, Tozer TN. 1979. Effect of altered plasma protein binding on apparent volume of distribution. J Pharm Sci 68:1203-1205.
    • (1979) J Pharm Sci , vol.68 , pp. 1203-1205
    • Øie, S.1    Tozer, T.N.2
  • 21
    • 0041664968 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetics from animal data and molecular structural parameters using multivariate regression analysis: Volume of distribution at steady state
    • Wajima T, Fukumura K, Yano Y, Oguma T. 2003. Prediction of human pharmacokinetics from animal data and molecular structural parameters using multivariate regression analysis: Volume of distribution at steady state. J Pharm Pharmacol 55:939-949.
    • (2003) J Pharm Pharmacol , vol.55 , pp. 939-949
    • Wajima, T.1    Fukumura, K.2    Yano, Y.3    Oguma, T.4
  • 22
    • 47749125276 scopus 로고    scopus 로고
    • Prediction of drug tissue to plasma concentration ratios using ameasured volume of distribution in combination with lipophilicity
    • Jansson R, Bredberg U, Ashton M. 2008. Prediction of drug tissue to plasma concentration ratios using ameasured volume of distribution in combination with lipophilicity. J Pharm Sci 97:2324-2339.
    • (2008) J Pharm Sci , vol.97 , pp. 2324-2339
    • Jansson, R.1    Bredberg, U.2    Ashton, M.3
  • 23
    • 78650529736 scopus 로고    scopus 로고
    • A hybrid approach to advancing quantitative prediction of tissue distribution of basic drugs in human
    • Poulin P, Ekin S, Theil FP. 2011. A hybrid approach to advancing quantitative prediction of tissue distribution of basic drugs in human. Toxicol Appl Pharmacol 250: 194-212.
    • (2011) Toxicol Appl Pharmacol , vol.250 , pp. 194-212
    • Poulin, P.1    Ekin, S.2    Theil, F.P.3
  • 24
    • 34548393250 scopus 로고    scopus 로고
    • Prediction of human pharmacokinetics: Evaluation of methods for prediction of volume of distribution
    • Fagerholm U. 2007. Prediction of human pharmacokinetics: Evaluation of methods for prediction of volume of distribution. J Pharm Pharmacol 59:1181-1190.
    • (2007) J Pharm Pharmacol , vol.59 , pp. 1181-1190
    • Fagerholm, U.1
  • 26
    • 34748919740 scopus 로고    scopus 로고
    • Interspecies prediction of human drug clearance based on scaling data from one or two animal species
    • Tang H, Hussain A, Leal M, Mayersohn M, Fluhler E. 2007. Interspecies prediction of human drug clearance based on scaling data from one or two animal species. Drug Metab Dispos 35:1886-1893.
    • (2007) Drug Metab Dispos , vol.35 , pp. 1886-1893
    • Tang, H.1    Hussain, A.2    Leal, M.3    Mayersohn, M.4    Fluhler, E.5
  • 27
    • 33646124969 scopus 로고    scopus 로고
    • A novel strategy for physiologically based predictions of human pharmacokinetics
    • Jones HM, Parrott N, Jorga K, Lave T. 2006. A novel strategy for physiologically based predictions of human pharmacokinetics. Clin Pharmacokinet 45(5):511-542.
    • (2006) Clin Pharmacokinet , vol.45 , Issue.5 , pp. 511-542
    • Jones, H.M.1    Parrott, N.2    Jorga, K.3    Lave, T.4


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