ECTS
120 credits
Duration
2 years
Training structure
Faculty of Pharmacy
Language(s) of instruction
French
Presentation
Training on the evaluation of the safety of health products: pharmacology, toxicology, pharmacokinetics, from raw materials to finished products.
Objectives
Quality assurance and safety of health products, particularly in the context of their non-clinical development.
Know-how and skills
- To know the regulatory requirements for the evaluation of the safety of health products from raw materials (active ingredients, impurities, residual solvents, heavy metals, polymorphism, stability, ...) to finished products (drugs, cosmetics, medical devices ...).
- Know how to elaborate toxicological investigation protocols: know the general aspects (choice of species, doses, evaluation of metabolites, QSAR ...), the regulatory evaluation methods (Toxicity by single administration, by repeated administration, mutagenesis, carcinogenesis, reprotoxicity, immunotoxicity, local tolerance, transcutaneous passage, phototoxicity ...) and the alternative methods
- Know how to design safety pharmacology studies: regulatory aspects, " core battery ", complementary studies, pediatric investigation plan, alternative methods, etc.
- Understand the principles, expected results and limitations of pharmacokinetic studies performed for the filing of MA(in silico, in vitro, in vivo), interpret pharmacokinetic data from population pharmacokinetic modeling (quantification of variability and identification of sources of variability likely to impact the safety of drug administration), take into account the pharmacokinetic specificities of innovative drugs such as nanomedicines and biotherapies