General provisions

Substituting a corresponding earlier course 3FX117 or 3FX400, Toxicology, drug metabolism and safety assessment.

Entry requirements

The general rules laid down by the Curriculum Committee of the Faculty of Pharmacy apply (see programme curriculum).

Learning outcomes

Having completed the course, the student shall have a knowledge of the mechanisms behind a drug's potentially toxic, carcinogenic, teratogenic and reproduction toxicological effects, the most important metabolic reactions and the importance of metabolism for a drug's pharmacokinetic, pharmacological and toxicological properties. The student shall also have a good knowledge of how toxicological risk assessment and safety evaluation are performed in practice and be able to utilise this knowledge to assess reported clinical side effects in humans. Having completed the course, the student shall have a thorough knowledge of toxicology and drug metabolism and their role in drug development and pharmacotherapy.

Content

The course will mainly deal with basic toxicology, biotransformation and toxicological risk assessment/safety evaluation. The following topics will be included: Basic toxicological concepts; phase I and II metabolism; biochemical properties and polymorphism of metabolic enzymes and pharmacogenetics; enzyme induction and inhibition; mechanisms behind adverse effects of drugs and other chemical substances on large organ systems; genetic toxicology; chemical carcinogenesis; embryotoxicity/teratogenicity; reproduction assessment toxicity; immunotoxicity and general principles of toxicological risk and safety evaluation.

The course will also include a more basic introduction to the following topics: Methods of studying drug metabolism and toxicity in drug development; the importance of biotransformation for bioavailability, pharmacokinetics and individual sensitivity to drugs and the role of metabolism in drug side effects and interactions.

Instruction

The course comprises lectures, seminars and demonstrations and/or laboratory sessions.

Compulsory parts of the course: Participation in laboratory sessions/demonstrations.

Assessment

Written examinations are held at the end of the course. Students are required to pass the written examination (examination code) and compulsory parts of the course (examination code). Repetition of compulsory parts of the course may be done in connection with the next course at the earliest and then only if there is a vacancy.