Analytical Methods for Dose and Plasma Determinations

GLP regulations require confirmation of the potency of all formulations used in non-clinical studies. Furthermore, current ICH guidelines also require toxicokinetic data (i.e. animal pharmacoki-netics determined at one or more time points during a non-clinical toxicology study). Both the potency and toxicokinetic assays require an analytical method for the determination of parent drug (and possible major metabolites) in solvents and plasma, usually validated for multiple non-clinical species.

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