From the latest technologies used in drug discovery through to post market surveillance activities – this module looks at the stages involved in the multimillion-pound process of drug product development. The module covers the typical “time-line” of drug product development, including Issues and importance of stages in drug product development; Drug discovery; Developability; Preformulation, primary and secondary manufacturing; Quality by design approaches to pharmaceutical manufacturing; Pre-clinical studies and clinical studies; The regulatory and quality environment of the pharmaceutical industry; Marketing and post marketing activities; Patents and protection intellectual property.
Learning Outcomes
By the end of the module the student should be able to:
Describe and demonstrate an understanding of the drug discovery process;
Describe and demonstrate an understanding of the key stages in the development of a pharmaceutical drug product;
Demonstrate an understanding of the regulatory, patent and quality environment of the pharmaceutical industry;
Demonstrate an understanding of and evaluate current and emerging strategies for improving pharmaceutical manufacturing processes.