General provisions

This course substitutes and corresponds to 3FK029.

This course is given in English.

Entry requirements

Admitted to the Master Programme in Drug Discovery, Master Programme in Pharmaceutical Modelling and Development or in Biomedicine. For the Master of Science in Pharmacy Programme, 150 credits are required within the programme. Enrolment in all compulsory courses within the first to seventh semester is also required. For Bachelor of Science in Pharmacy 120 credits are required within the programme, including the following courses Organic Pharmaceutical Chemistry, Pharmacology, Structure and Analysis of Drugs, Pharmacokinetics and Statistics, Pharmaceutics and Pharmaceutical Physical Chemistry. Enrolment in all compulsory courses within the first to fifth semester is also required.

For the Master of Science Programme in Chemical Engineering, at least 150 credits are required within the programme including organic chemistry and medicinal chemistry. For non-programme students a Bachelor of Pharmaceutical Science, Chemical Engineering or equal degree is required (180 credits). Knowledge in English equivalent to that required for basic eligibility to Swedish higher education.

Learning outcomes

On completion of the course, the student should be able to:

KNOWLEDGE AND UNDERSTANDING

- Describe and justify the role and importance of the various disciplines involved in the different phases of drug discovery and development

- Account for decision points in the drug development process

- Explain how methods for predictions are used to make early decisions in the drug discovery and development

COMPETENCE AND SKILLS

- Carry out searches to retrieve information relevant to the development of a new drug.

- Construct, review and evaluate preclinical and clinical pharmaceutical studies with a general understanding of aim, choice of procedures, results, conclusions and importance.

JUDGEMENT AND APPROACH

- Evaluate scientific, ethical and market-related considerations of importance in the drug development.

Content

The course deals with the different phases in drug development: Identification and optimisation of active substance towards selected macromolecular target, ADME-Tox profiling, in-vivo and in-vitro pharmacology, formulation, biomarkers and disease models, clinical trials, registration and commercialisation.

Instruction

The course consists of lectures, oral and written presentations, workshops, seminars and self-study of literature. The course may be given in English.

Compulsory parts of the course:

workshops and literature work

Assessment

The examination will take place at the end of the course. To pass the course one must: pass the examination (examination code) and receive a passing grade in the literature work (examination code), beside taking part in the compulsory parts of the course..

Re-taking failed compulsory parts of the course can occur, at the earliest, at next course and then only if the course is not full.

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University's disability coordinator.

Other directives

The course may be given in English.