Strategic Guidance for Evidence-Based Preclinical Development
At HSP Research Group LLP, we provide scientific guidance for planning and coordinating preclinical evaluation programs for pharmaceutical, novel drug-delivery, herbal, phytopharmaceutical, nutraceutical and selected healthcare products.
Our role is focused on helping clients develop a scientifically appropriate preclinical strategy, select relevant models and endpoints, support protocol development, coordinate specialized CRO or testing-facility activities, and interpret the resulting data in the context of product development.
Preclinical programs should be designed according to the nature of the product, intended indication, route of administration, anticipated clinical use and stage of development. ICH M3(R2) emphasizes that nonclinical development programs should be scientifically and ethically appropriate and may involve pharmacology, general toxicity, toxicokinetic/pharmacokinetic, reproductive toxicity and genotoxicity studies, with additional studies determined according to the product and development context.
