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By Wilkins Martin

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Van de Waterbeemd H. High-throughput and in silico techniques in drug metabolism and pharmacokinetics. Curr Opin Drug Discov Devel 2002; 5:33–43. Oakley AJ, Wilce MC. Macromolecular crystallography as a tool for investigating drug, enzyme and receptor interactions. Clin Exper Pharmacol Physiol 2000; 27:145–51. Oprea TI, Gottfries J. Toward minimalistic modeling of oral drug absorption. J Mol Graph Model 1999; 17: 261–74. Lipinski CA, Lombardo F, Dominy BW, Feeney PJ. Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings.

A frequent design is to use three dose levels, the highest one close to the maximum safe dose in the single-dose study. If the drug is known to have a half-life that substantially exceeds 24 hours, the dosage schedule may have to be modified. The main aims are to obtain pharmacokinetic information at steady-state and safety data during more prolonged administration. Special attention will be given to compounds that have non-linear kinetics or active metabolites. A very different metabolic profile in man from those seen in animals may require further animal studies to establish safe exposure limits for the metabolites.

The studies may be modified in the light of findings in humans or animals, or additional studies may be conducted, particularly to investigate the mechanism underlying an adverse effect. Major human metabolites not formed by the nonclinical species, and impurities formed during synthesis or breakdown of the active substance may require testing. Post-launch nonclinical studies may be requested by regulatory agencies (‘Phase IV commitments’), or rare adverse events identified only in large patient populations after marketing may trigger further laboratory investigation.

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