Clinical Trials
What is a clinical trial? Clinical trials are research studies, in which a reference medicinal product (original), that exists on the market and generic medicine, which contains the same active ingredient, in the same quantity, is administered to healthy subjects, in order to compare concentrations in biological matrices (blood, urine, saliva, etc.) All procedures are performed related to a clinical trial according to the protocol approved by the National Agency for Medicines, Medical Devices, and the National Commission for Bioethics Medicines and Medical Devices. What are the 4 phases of clinical trials? Phase Primary goal Phase I Dose-ranging on healthy volunteers for safety Phase II Testing of the drug on participants to assess efficacy and side effects Phase III Testing of a drug on participants to assess efficacy, effectiveness, and safety Phase IV Postmarketing surveillance in public The Drug Development Process Step 1: Discovery and Development. Step 2: Preclinical Researc...