Module 9: Drug Development and Pharmacogenetics

Introduction [forthcoming]

At its core, drug development aims to create therapies that are both safe and effective. However, achieving these goals requires overcoming significant scientific, technical, regulatory, and financial challenges. The path from identifying a promising compound to gaining regulatory approval for widespread use is long, expensive, and fraught with risk. (Atkins-Ball, D., Bolden, C., LaVance, A., Lenard, N., Moore, M., & Nichols, a. C. (2027). Introduction to Pharmacology. (D. T. White, Ed.) Baton Rouge: LOUIS: Louisiana Library Network. Retrieved from https://louis.pressbooks.pub/pharmacology/)

Image: Scientists learn key aspects of the mRNA vaccine production process at the NIAID Vaccine Research Center. Source: "Training on mRNA Vaccine Production at the NIAID Vaccine Research Center" by NIAID is licensed CC BY 2.0.

Learning Objectives

Upon completion of this module, you will be able to:

1. Describe the major stages of drug development, from discovery through clinical trials to FDA approval
2. Explain the purpose and design of preclinical studies and the phases of clinical research (Phase I–IV)
3. Define key regulatory concepts, including Investigational New Drug (IND) applications and New Drug Applications (NDA)
4. Discuss the principles and goals of pharmacogenetics and how genetic variation influences drug metabolism and response
5. Identify examples of genetic polymorphisms that impact drug efficacy and safety (e.g., CYP450 enzymes, HLA alleles)
6. Understand how pharmacogenetic testing can guide personalized medicine and optimize therapeutic outcomes
7. Analyze ethical, legal, and social issues related to pharmacogenetic data in clinical practice

To achieve these objectives: 

1. Read the Module 9 Introduction 
   
2. Read Chapter 12. Drug Development and Pharmacogenetics in Introduction to Pharmacology - aligns with computer proficiency
3. Complete the Module 9 Discussion Forum - aligns with computer proficiency, internet navigation, digital communication, and collaboration
4. Complete the Module 9 Quiz - aligns with computer proficiency 

Module Pressbooks Resources and Activities