Phase drug metabolism

E (1997) Mechanism of action of dietary chemoprotective agents in rat liver induction of phase I and II drug metabolizing enzymes and aflatoxin B1 metabolism . Carcinogenesis, 18 1729-38. 

Phase I The preliminary studies in humans are designed to evaluate the pharmacokinetics and the acute toxicity/tolerability of the potential dmg. Usually, phase I studies are carried out in a very small population [15—40] of healthy male volunteers. Thus, the nature of the population tested and the small number of individuals involved limits the scope of pharmacogenomics to the study of genetic variability in drug metabolism. 

It has now been established that genetic polymorphisms in drug metabolizing enzymes such as the cytochrome P450s (CYP) and the phase II enzyme, thiopu-rine methyltransferase, are responsible for inter-individual variability in response and adverse reactions [12, 13]. However, at the present time, the impact of poly-... 

Human pharmacology (Phase I) Assess tolerance Define/describe pharmacokinetics and pharmacodynamics Explore drug metabolism and drug interactions Estimate activity Dose-tolerance studies Single and multiple dose PK and/or PD studies Drug interaction studies... 

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