The best model for humans is human - How to accelerate early drug development safely

Alternatives to Laboratory Animals

Volumn 37, Issue SUPPL. 1, 2009, Pages 61-65

  Seymour, Mark ^a  

^a Xceleron Ltd   (United Kingdom)

Author keywords

Absolute bioavailability; Accelerator mass spectrometry; Intravenous pharmacokinetics; Metabolites in safety testing; Microdosing

Indexed keywords

CARBON 14;

BIOLOGICAL MODEL; CONFERENCE PAPER; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; DRUG BIOAVAILABILITY; DRUG DEVELOPMENT; DRUG SAFETY; HUMAN; MASS SPECTROMETRY; METABOLISM; MICRODOSIMETRY; NONHUMAN; PHARMACOKINETICS; PREDICTION; PRIORITY JOURNAL; VALIDATION PROCESS;

ANIMALIA;

EID: 70449566548     PISSN: 02611929     EISSN: None     Source Type: Journal    
DOI: 10.1177/026119290903701s09     Document Type: Conference Paper

References (6)

1. Kaye, B., Garner, R.C., Mauthe, R.J., Freeman, S.P.H.T. & Turteltaub, K.W. (1997). A preliminary evaluation of accelerator mass spectrometry in the biomedical field. Journal of Pharmaceutical & Biomedical Analysis 16, 541-543. (Pubitemid 27514399)
2. Lappin, G., Kuhnz, W., Jochemsen, R., Kneer, J., Chaudhary, A., Oosterhuis, B., Drijfhout, W.J., Rowland, M. & Garner, R.C. (2006). Use of microdosing to predict pharmacokinetics at the therapeutic dose: experience with 5 drugs. Clinical Pharmacology & Therapeutics 80, 203-215.
3. Lappin, G. & Garner, R.C. (2008). The utility of microdosing over the past 5 years. Expert Opinion on Drug Metabolism & Toxicology 4, 1499-1506.
4. Nagilla, R. & Ward, K.W. (2004). A comprehensive analysis of the role of correction factors in the allometric predictivity of clearance from rat, dog, and monkey to humans. Journal of Pharmaceutical Sciences 93, 2522-2534. (Pubitemid 39319435)
5. Ward, K.W., Nagilla, R. & Jolivette, L.J. (2005). Comparative evaluation of oral systemic exposure of 56 xenobiotics in rat, dog, monkey and humans. Xenobiotica 35, 191-210. (Pubitemid 40769767)
6. FDA (2008). Guidance for Industry: Safety Testing of Drug Metabolites. Available at: http://www.fda.gov/cder/guidance/6897fnl.pdf (Accessed 29.05.09). Rockville, MD, USA: US Department of Health & Human Services, Food & Drug Administration, Center for Drug Evaluation and Research (CDER).