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Page 265 Fig. 1 Drug discovery and development process. available. Kinetic and metabolic profiling continues throughout clinical development and an investigational new drug (IND) application routinely contains a considerable quantity of pharmacokinetic and metabolism data. While very little pharmacokinetic and metabolism data are officially required by most regulatory agencies, companies are generally too cautious to submit less than a fairly complete package. The spectrum of preclinical studies that may be conducted for IND submission, and beyond, is given in Table 1. Table 1 Nonclinical Studies Involving Pharmacokinetics Analytical development Bioavailability, two species Biopharmaceutical profile Mass balance, two species Autoradiography Single-dose pharmacokinetics Multiple-dose pharmacokinetics Protein binding Dose proportionality Pharmacokinetic/pharmacodynamic relationships Dose ranging, toxicology, two species Short-term toxicology, two species Long-term toxicology, two species Metabolism work-up in toxicity species Special toxicology studies
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