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Xenobiotica
the fate of foreign compounds in biological systems
Volume 52, 2022 - Issue 7
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General Xenobiochemistry

Utility of preclinical species for uncertainty assessment and correction of prediction of human volume of distribution using the Rodgers-Lukacova model

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Pages 661-668 | Received 09 Sep 2022, Accepted 01 Oct 2022, Published online: 11 Oct 2022

References

  • Berry LM, Li C, Zhao Z. 2011. Species differences in distribution and prediction of human V(ss) from preclinical data. Drug Metab Dispos. 39(11):2103–2116.
  • Chan R, De Bruyn T, Wright M, Broccatelli F. 2018. Comparing mechanistic and preclinical predictions of volume of distribution on a large set of drugs. Pharm Res. 35(4):87.
  • Cook D, Brown D, Alexander R, March R, Morgan P, Satterthwaite G, Pangalos MN. 2014. Lessons learned from the fate of AstraZeneca’s drug pipeline: a five-dimensional framework. Nat Rev Drug Discov. 13(6):419–431.
  • Grime K, Paine SW. 2013. Species differences in biliary clearance and possible relevance of hepatic uptake and efflux transporters involvement. Drug Metab Dispos. 41(2):372–378.
  • Graham H, Walker M, Jones O, Yates J, Galetin A, Aarons L. 2012. Comparison of in-vivo and in-silico methods used for prediction of tissue: plasma partition coefficients in rat. J Pharm Pharmacol. 64(3):383–396.
  • Kimoto E, Bi Y-A, Kosa RE, Tremaine LM, Varma MVS. 2017. Hepatobiliary clearance prediction: species scaling from monkey, dog, and rat, and in vitro–in vivo extrapolation of sandwich-cultured human hepatocytes using 17 drugs. J Pharm Sci. 106(9):2795–2804.
  • Lukacova V, Parrott N, Lave T, Fraczkiewicz G, Bolger M, Woltosz W. 2008. General approach to calculation of tissue: plasma partition coefficients for physiologically based pharmacokinetic (PBPK) modeling. AAPS National Annual Meeting and Exposition; November; Atlanta, GA; p. 17–19.
  • Martinez MN, Mochel JP, Neuhoff S, Pade D. 2021. Comparison of canine and human physiological factors: understanding interspecies differences that impact drug pharmacokinetics. AAPS J. 23(3):59.
  • Mathew S, Tess D, Burchett W, Chang G, Woody N, Keefer C, Orozco C, Lin J, Jordan S, Yamazaki S, et al. 2021. Evaluation of prediction accuracy for volume of distribution in rat and human using in vitro, in vivo, PBPK and QSAR methods. J Pharm Sci. 110(4):1799–1823.
  • Miller NA, Reddy MB, Heikkinen AT, Lukacova V, Parrott N. 2019. Physiologically based pharmacokinetic modelling for first-in-human predictions: an updated model building strategy illustrated with challenging industry case studies. Clin Pharmacokinet. 58(6):727–746.
  • Peters SA. 2012. Hypothesis generation and pharmacokinetic predictions. In: Physiologically-based pharmacokinetic (PBPK) modeling and simulations: principles, methods, and applications in the pharmaceutical industry. Hoboken (NJ): Wiley. p. 273–298.
  • Peters SA, Petersson C, Blaukat A, Halle J-P, Dolgos H. 2020. Prediction of active human dose: learnings from 20 years of Merck KGaA experience, illustrated by case studies. Drug Discov Today. 25(5):909–919.
  • Petersson C, Papasouliotis O, Lecomte M, Badolo L, Dolgos H. 2020. Prediction of volume of distribution in humans: analysis of eight methods and their application in drug discovery. Xenobiotica. 50(3):270–279.
  • Poulin P, Collet SH, Atrux-Tallau N, Linget J-M, Hennequin L, Wilson CE. 2019. Application of the tissue composition–based model to minipig for predicting the volume of distribution at steady state and dermis-to-plasma partition coefficients of drugs used in the physiologically based pharmacokinetics model in dermatology. J Pharm Sci. 108(1):603–619.
  • Poulin P, Theil F‐P. 2002. Prediction of pharmacokinetics prior to in vivo studies. 1. Mechanism‐based prediction of volume of distribution. J Pharm Sci. 91(1):129–156.
  • Rodgers T, Rowland M. 2007. Mechanistic approaches to volume of distribution predictions: understanding the processes. Pharm Res. 24(5):918–933.
  • Ruark CD, Hack CE, Robinson PJ, Mahle DA, Gearhart JM. 2014. Predicting passive and active tissue: plasma partition coefficients: interindividual and interspecies variability. J Pharm Sci. 103(7):2189–2198.
  • Schmitt MV, Reichel A, Liu X, Fricker G, Lienau P. 2021. Extension of the mechanistic tissue distribution model of Rodgers and Rowland by systematic incorporation of lysosomal trapping: impact on unbound partition coefficient and volume of distribution predictions in the rat. Drug Metab Dispos. 49(1):53–61.
  • Shen H, Yang Z, David Rodrigues A. 2022. Cynomolgus monkey as an emerging animal model to study drug transporters: in vitro, in vivo, in vitro-to-in vivo translation. Drug Metab Dispos. 50(3):299–319.
  • 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(10):1886–1893.

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