Physiologically based pharmacokinetics in drug development and regulatory science: A workshop report (Georgetown University, Washington, DC, May 29-30, 2002)

AAPS Journal

Volumn 6, Issue 1, 2004, Pages

  Rowland, Malcolm ^a   Balant, Luc ^b   Peck, Carl ^c  

^a UNIVERSITY OF MANCHESTER   (United Kingdom)

^b UNIVERSITY OF GENEVA   (Switzerland)

^c GEORGETOWN UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ISOTRETINOIN; NEW DRUG; RETININ A; RETINOIC ACID; RETINOIC ACID DERIVATIVE; THALIDOMIDE; UNCLASSIFIED DRUG;

ANIMAL TESTING REDUCTION; ARTICLE; CLINICAL TRIAL; COMPARTMENT MODEL; COMPUTER INTERFACE; COMPUTER MODEL; COMPUTER PROGRAM; COMPUTER SIMULATION; DRUG ABSORPTION; DRUG DISTRIBUTION; DRUG INDUSTRY; DRUG INFORMATION; DRUG METABOLISM; DRUG PROTEIN BINDING; DRUG RESEARCH; DRUG SAFETY; DRUG SELECTIVITY; DRUG SYNTHESIS; EDUCATION; ENVIRONMENTAL EXPOSURE; ENVIRONMENTAL PROTECTION; FACTUAL DATABASE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HUMAN; IN VITRO STUDY; IN VIVO STUDY; METHODOLOGY; NONHUMAN; RISK ASSESSMENT; SKIN DEFECT; STANDARDIZATION; TERATOGENICITY; TISSUE DISTRIBUTION; TOXICITY TESTING; UNITED STATES; VALIDATION PROCESS; WORKSHOP; WRINKLE; ANIMAL; BIOLOGICAL MODEL; CHEMISTRY; CONFERENCE PAPER; DRUG DESIGN; DRUG SCREENING; ENVIRONMENTAL HEALTH; LEGAL ASPECT; ORGANIZATION AND MANAGEMENT; PHARMACOKINETICS; TOXICOLOGY;

ANIMALS; CHEMISTRY, PHARMACEUTICAL; CLINICAL TRIALS; COMPUTER SIMULATION; DATABASES, FACTUAL; DRUG DESIGN; DRUG EVALUATION, PRECLINICAL; DRUG INDUSTRY; ENVIRONMENTAL HEALTH; HUMANS; MODELS, BIOLOGICAL; PHARMACOKINETICS; RISK ASSESSMENT; SOFTWARE; TOXICOLOGY;

EID: 34248680469     PISSN: 15507416     EISSN: None     Source Type: Journal    
DOI: 10.1208/ps060106     Document Type: Article

References (17)

1. Andersen ME. Development of physiologically based pharmacokinetic and physiologically based pharmacodynamic models for applications in toxicology and risk assessment. Toxicol Lett. 1995;79(1-3):5-44.
2. Bjorkman S, Wada B, Berling M, Benoni G. Prediction of disposition of midazolam in surgical patients by a physiologically based pharmacokinetic model. J Pharm Sci. 2001;90:1226-1241.
3. Bois FY Statistical analysis of Clewell et al. PBPK model of trichloroethylene kinetics. Environ Health Perspect. 2000;108(suppl 2):307-316.
4. Charnick SB, Kawai R, Nedelman JR, Lemaire M, Niederberger W, Sato H. Perspectives in pharmacokinetics. Physiologically based pharmacokinetic modeling as a tool for drug development. J Pharmacokinet Biopharm. 1995;23:217-229.
5. Clewell HJ, Andersen ME, Wills RJ, Latriano L. A physiologically based pharmacokinetic model for retinoic acid and its metabolites. J Am Acad Dermatol. 1997;36:S77-S85.
6. Clewell HJ, Gentry PR, Covington TR, Gearhart JM. Development of a physiologically based pharmacokinetic model of trichloroethylene and its metabolites for use in risk assessment. Environ Health Perspect. 2000;108(suppl 2):283-305.
7. Downing GJ, ed. Biomarkers and Surrogate Endpoints: Clinical Research and Applications, Proceedings of the NIH-FDA Conference, Bethesda, MD, 15-16 April 1999. New York, NY: Elsevier; 2000.
8. Gearhart JM, Jepson GW, Clewell HJ, Andersen ME, Connoly RB. A physiologically based pharmacokinetic model for the inhibition of acetylcholinesterase by organophosphate esters. Environ Health Perspect. 1995;102:51-60.
9. Holford NHG, Monteleone JPR, Kimko HC, Peck CC. Simulation of Clinical Trials. Annu Rev Pharmacol Toxicol. 2000;40:209-234.
10. Houston JB, Carlile DJ. Prediction of hepatic clearance from microsomes, hepatocytes, and liver slices. Drug Metab Rev. 1997;29:891-922.
11. Iwatsubo T, Hirota N, Ooie T, Suzuki H, Sugiyama Y. Prediction of in vivo drug disposition from in vitro data based on physiological pharmacokinetics. Biopharm Drug Dispos. 1996;17:273-310.
12. Kawai R, Mathew D, Tanaka C, Rowland M. Physiologically based pharmacokinetics of cyclosporine A: Extension to tissue distribution kinetics in rats and scale-up to human. J Pharmacol Exp Ther. 1998;287:457-468.
13. Poulin P, Theil FP. Prediction of pharmacokinetics prior to in vivo studies. II. Generic physiologically based pharmacokinetic models of drug disposition. J Pharm Sci. 2002;91:1358-1370.
14. Nestorov IA, Aarons LJ, Arundel PA, Rowland M. Lumping of whole-body physiologically based pharmacokinetic models. J Pharmacokinet Biopharm. 1998;26:21-46.
15. Nestorov IA. Whole body pharmacokinetic models. Clin Pharmacokinet. 2003;42:883-908.
16. Teorell T. Kinetics of distribution of substances administered to the body. I & II. Arch Int Pharmacodyn Ther. 1937;57:202-240.
17. Tsukamoto Y, Kato Y, Ura M, Horii I, Ishitsuka H, Kusuhara H, Sugiyama Y. A physiologically based pharmacokinetic analysis of capecitabine, a triple prodrug of 5-FU, in humans: The mechanism for tumor-selective accumulation of 5-FU. Pharm Res. 2001;18:1190-1202.