BPS2042 · Drug development

Overview

This unit will take you through the process of developing a drug candidate into a registered pharmaceutical product. This encompasses: pre-clinical development, including drug formulation based on the pharmacokinetic, pharmacodynamic and toxicological profile of a drug candidate; clinical trial regulation and design; intellectual property and marketing considerations. You will be introduced to the regulatory and commercial requirements as well as the scientific concepts underpinning the drug development processes. This unit also explores a range of career paths available in the pharmaceutical industry.

Offerings

Assessment

The Handbook does not list a final examination among the assessment items. That is not a guarantee there is none.

In-semester assessment 100%

Assessment details may change. Please refer to the assessment information in Moodle closer to the start of the teaching period.

Requisites

Learning outcomes

1. Explain the scientific and regulatory stages involved in taking a drug candidate to a registered pharmaceutical product.
2. Explain the basis of pre-formulation tests to inform formulation decisions.
3. Evaluate formulation options for a drug candidate with regard to medical, technical and commercialisation considerations.
4. Propose pre-clinical tests for a drug candidate to provide evidence for its safety.
5. Differentiate between the phases of a clinical trial.
6. Discuss the commercial lifecycle of a pharmaceutical product, the importance of intellectual property and marketing considerations.
7. Identify and describe a range of jobs that exist in the pharmaceutical industry.

Workload

• Twelve 1-hour online preparation modules (Discovery) • Twenty-four 1-hour interactive online modules • Twelve 1-hour applied sessions (Q&A) • Eleven 2-hour workshops • One 4-hour workshop (GMP)

Student experience, not official rules. Nothing here changes what the Handbook says.