CRPV102 Introduction to Non-Clinical and Clinical Research

Taking a new pharmaceutical product from the laboratory to the market requires years of bench research, and nonclinical research to assess the safety profile of the new drug. The most important element of the early discovery process is to select the best new molecular entities to enter clinical trials and to limit failure in full development. The next phase is careful clinical research on human subjects to assess the safety and efficacy of your product, constant interactions with FDA, manufacturing your product in the most efficient manner compliant with the appropriate regulations, and finally assembling a high-quality application that will be accepted and approved by the FDA.

This course is designed to introduce the students to the main steps of the drug development process, from drug discovery, and preclinical animal testing to all phases of clinical research and post-approval drug safety surveillance from the US and international regulatory perspectives.

Learning Points:

• Drug Discovery Process
• Drug development in the Pre-clinical Laboratory Testing (toxicity studies)
• International Regulatory Framework of Preclinical Testing (GLP) and US Regulatory Standards of Clinical Studies Authorization
• Maximum Recommended Safe Dose (MRSD)
• Phase I First-In-Human Studies
• Objectives and Designs of all Clinical Phases