SMIMB1051U Non-clinical Safety and Toxicology
Master's Programme in Industrial Drug Development -
Compulsory for Master of Industrial Drug Development (MIND) students, elective for other part-time master's students at the Faculty of Health and Medical Sciences (subject to study board approval) and open for freelance students who meet the admission criteria.
The course is intended for drug development professionals who need basic knowledge in safety or who need a brush-up course for continuing professional development (CPD).
The course concerns investigations used in the non-clinical safety assessment of new drugs. These include evaluation of general toxicity and safety pharmacology, genotoxicity, carcinogenicity, and reproductive toxicity but also aspects of ADME (absorption, distribution, metabolism, excretion) and toxicokinetics in relevant species. Studies to elucidate the mechanism of changes seen in target organs/tissues will also be discussed. Rationalizations with respect to study programme, predictivity and translational aspects of the safety assessment will be described, as well as an outline of future trends.
After introduction to factual rules and regulations, methodologies and data, participants will be presented with case stories, which they have to evaluate, discuss and finally provide recommendations upon in plenum.
Non-clinical safety assessment of a potential pharmaceutical represents an important part of the drug development process. Due to the high attrition rate seen late in development programmes this has caused an intensification and expansion of the field of safety science, the modern term for toxicology. Thus a much more integrated view is currently applied. These new trends in toxicological assessments will be reflected in the course.
The objective of the course is to introduce participants to non-clinical safety assessment and to give participants an insight in the requirements and the conclusions to be drawn from the results of non-clinical safety studies conducted in vivo as well as in vitro.
On completion of the course, participants are expected to be able to:
- Provide information on regulatory requirements for studies used in non-clinical safety assessment and the content of application to the authorities.
- Describe the major organ systems to be examined in non-clinical safety assessment
- List some predictive toxicological biomarkers.
- Outline special conditions for assessment of the toxicological aspects of large molecules.
- Recall in vivo reproduction in toxicology.
- Demonstrate insight and understanding of the requirements for non-clinical safety assessment in vivo as well as in vitro.
- Identify relevant animal species and/or organs/tissues used in safety studies.
- Devise in vitro genotoxicity tests.
- Provide information on specific guidelines regarding safety studies, methodology and data handling.
- Review and assess safety data presented for a given drug candidate
- Elucidate the mechanism of changes seen on target organ/tissue.
- Justify ADME toxicity related issues in relevant species incl. drug metabolites and toxicokinetics.
- Integrate the various safety aspects in the overall assessment for selection of drug candidates.
Approximately 125 pages from The Textbook of Pharmaceutical Medicine, 6th edition (2010) Eds.: John Griffin and John O'Grady, Blackwell BMJ Books (exact chapters will be specified later) plus hand-outs from course presentations.
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
- 2,5 ECTS
- Type of assessment
- Written examination, 2 hours under invigilationExamination design: The purpose of the examination is to test whether the examinee has a broad knowledge and comprehension of non-clinical toxicology and safety pharmacology studies, overall safety assessment and relevant regulatory requirements for new drugs in development. The test is composed of multiple choice questions with one or more possible answers.
The percentage of questions in the test, devoted to a particular topic, will roughly correspond to the emphasis given these topics during the course, and as implied in the general course objectives.
- All aids allowed
Apart from the standard programs and IT tools listed under The Faculty of Health and Medical Sciences at http://pc-exam.ku.dk/it_tools/health/ students will at this exam also have access to use a USB stick (for notes etc.)
- Marking scale
- 7-point grading scale
- Censorship form
- External censorship
Criteria for exam assesment
The grade 12 is given when the examinee:
- demonstrates a well structured presentation with a clear outline providing exact and correct answers.
- demonstrates aplomb comprehensive view
- combines convincingly the learned elements
- demonstrates with few unimportant deficits: aplomb mastering of relevant terms, principles and methods used for performing a non-clinical assessment of a drug candidate.
The grade 7 is given when The examinee:
- demonstrates a coherent presentation providing understandable unambiguous answers, the great majority of which should be correct.
- documents a certain overview over the learned elements
- demonstrates with minor deficits a firm knowledge of relevant terms, principles and methods used for performing a non-clinical assessment of a drug candidate.
The grade 02 is given when the examinee:
- demonstrates a less structured presentation with less precise answers.
- demonstrates a limited overview and the ability to combine learned elements is limited.
- demonstrates only to a limited extent and with a number of deficits capability to handle relevant terms, principles and methods used for performing a non-clinical assessment of a drug candidate.
- Theory exercises