Learning Outcomes:
On successful completion of this module students should be able to:
-Describe the development process from discovery of a molecule to administration as a medicine to patients
-Be able to discuss rational drug design and high throughput screening in Discovery
-Assess pharmacokinetic studies in working out doses and tissue target concentrations
-What are the safety requirements needed before a drug can be approved?
-Cite clinical trial case studies of recent drugs that have been approved for major diseases
-Cite examples of drug delivery technologies for non-injected delivery of biotech molecules
-Know the requirements and outputs examined for clinical trials in Phases 1-4
-Be able to write an essay on attrition causes in clinical development and possible remedies
-Understand how biomarkers can be used in Development
-How prodrugs of small molecules can be used to improve pharmacokinetic profiles
Indicative Module Content:
This module covers all the elements that go into a discovery programme for a new chemical entity along with its development in going from a lead to a hit. From preclinical studies in animals and cells covering toxicology and the processes of pharmacokinetics and pharmacodynamics, we then move into the clinical development phases, right through to FDA approval. We saw that in 2022 the clinical development process is flexible and can be expedited by parallel rather than linear movement between clinical phases where the next stage can start without full reporting of the current phase. This can be accompanied by review at breakneck speed by the Regulators in an emergency pandemic - this can allow emergency use of essential drugs and vaccines.