Preclinical Science

*Please note that applicants to this short course should go via King's Apply (click red 'Apply' button on the right of this page) and select the following programme*:

Pharmaceutical Medicine Non-Award (Part-time)

Module Code: 7BBP0002

This module covers three major areas: The pharmacology part of the module will include basic principles, plus the use of animal models, including transgenic models. Students will see how the pharmacology studies inform the choice of drug candidates and will learn of the importance of preclinical safety testing, including what tests are needed to start and progress a clinical development programme. Students will learn about the regulatory requirements for toxicology studies and how to look for critical information within a toxicology report. The module will also introduce aspects of pharmaceutical sciences, including the choice of formulation, stability testing, scale-up and how these issues can impact on a clinical trial programme.

• The aim of the module is to introduce students to the three main areas of pre-clinical science so that they will be better able to contribute to a product development plan and appreciate how the knowledge obtained can inform clinical trial design and a risk management plan.
• Students will be given instruction in the principles and application of pharmacology, toxicology and pharmacy as they apply to the discovery and development of new medicines.
• Students will work in syndicates to select a new asthma medicine for development and then take it through the preclinical development programme.
• They will have problems to solve during the project that will enable them to think about the lessons they have learned and work through complex obstacles.

• Have an understanding of the choice and predictive value of the non-clinical testing programme as part of the overall drug development plan for chemical and biological compounds.
• Be able to review a preclinical pharmacology programme and hypothesise how this might translate into human physiology and pharmacology.
• Be able to describe the limitations of animal models of disease.
• Be able to describe the general principles of non-clinical safety testing and how they help inform the clinical development process.
• Know how non-clinical tests are integrated into the overall drug development plan (including scheduling of toxicology tests with respect to clinical trials).
• Have an understanding of the molecular and cellular basis of toxic reactions.
• To be able to use animal pharmacokinetics and toxicokinetics to inform the clinical development process.
• Have an understanding of the pharmaceutical development of a drug substance and final drug product (including chemical and biological compounds).

Minimum entry requirements are either a medical degree (such as an MBBS) or a 2:1 first degree in pharmacy, pharmacology, biology, biochemistry, chemistry or related subject.

Suitable for industry physicians, medical affairs and regulatory affairs personnel.