Drug discovry and development : Master 1 Pharmaco-Toxicology

Abstract

The course "Drug Design and Development" is designed for first-year Master’s students in pharmaco-toxicology option. It offers a comprehensive overview of the modern drug development process, from target identification to clinical trials and regulatory approval. The main objective of the course is to provide students with a clear understanding of how new drugs are discovered, designed, optimized, and brought to market. Emphasis is placed on both theoretical principles and practical applications, preparing students for future research or industry roles. The course begins with an introduction to drug discovery, including a historical overview and the classification of drug types and molecular targets such as enzymes, receptors, and nucleic acids. It then explores methods for target identification and validation using in silico, in vitro, and in vivo approaches. Students will learn about various strategies for identifying lead compounds , including high-throughput screening, rational drug design, and the use of natural products. The process of lead optimization is covered in detail, focusing on structure-activity relationships (SAR) and ADMET properties, which are crucial for ensuring efficacy and safety. The course also covers preclinical development, including pharmacokinetics, pharmacodynamics, and toxicological testing in animal models. This is followed by an in-depth look at clinical development, outlining the four phases of clinical trials, study design, ethical considerations, and data analysis. Regulatory frameworks are discussed, with attention given to agencies like the FDA (Food and Drug Administration) and EMA (European Medicines Agency), and the requirements for submitting investigational new drug (IND) and new drug application (NDA) dossiers. Finally, the course highlights emerging trends and challenges in the field, such as the integration of artificial intelligence in drug discovery, personalized medicine, and the development of treatments for rare diseases.