The aim of the module is to describe the processes involved in the discovery, development and testing of a new molecule, i.e. its journey from the laboratory bench to clinical use. Drug discovery and sources of new drugs are discussed first, with detailed discussions on the use of modern methods in the synthetic and structural elucidation processes. Medicinal chemistry principles are introduced and illuminated by real-life examples. The legal aspects of drug development, such as clinical trials, safety assessment studies, the worldwide regulatory framework and post-marketing surveillance and pharmacovigilance, are considered. Conventional drug delivery methods, e.g. immediate-release and controlled release solid oral dosage forms, are described in detail along with their underpinning physical science. Pharmacokinetic principles are revisited and their importance stressed.

Learning Outcomes 

At the end of this module students should be able to:

1. Describe the sources of drugs, including relevant examples.
	2. Explain the principles of medicinal chemistry as applied to the discovery and development of new drugs.
	3. Explain the principles of NMR and mass spectrometry and be able to analyse relatively simple spectra correctly.
	4. Discuss fundamental materials science and its relevance to formulation science.
	5. Describe how conventional oral solid dose formulations are developed, formulated, produced and tested, taking into account relevant patient-related and drug-related factors.
	6. Describe how conventional rectal and vaginal formulations are developed, formulated, produced and tested, taking into account relevant patient-related and drug-related factors.
	7. Describe the legal framework in which drugs are developed.
	8. Accurately perform pharmacokinetic calculations.
	9. Formulate, prepare and analyse solid oral dosage forms.
	10. Describe and select appropriate packaging material for a drug substance or formulated pharmaceutical product.
	11. Effectively and appropriately interpret and use numerical data.
	12. Analyse and solve complex problems accurately.
	13. Ability to work both independently and in a group.
	14. Communicate complex information and conclusions in a written report format.