Safety Pharmacology

Current regulations require general toxicology study in monkeys before a compound being developed in human. While the general toxicology studies drug toxicity in normal subjects, however, some of key safety, toxicity, adverse effect, and side-effect issues in relevant to disease treatment are better to be explored before advancing a drug compound to the costly regulated studies in preclinical development or along the earlier clinical trials. Elucidating the safety concerns of a drug with targeted clinical indication, therapeutic beneficial, and clinical relevant doses, can greatly help in the sound design of its clinical studies and reduction of its risks in later stage development. Prisys provides a broad selection of monkey models, which renders susceptible physiological and pathological statuses, to evaluate the effects and margins of safe treatment, the possible adverse effects, and the preliminary toxicity of a drug compound at ranges of its therapeutic doses, generating answers to the inter-correlated ‘safety-pharmacology’ questions prior to its preclinical and clinical development.