SMIMB1051U Non-clinical Safety and Toxicology

Volume 2013/2014
Education
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).
Content
The course concerns investigations used in non-clinical safety assessment by identifying the "target organ/tissue" and doing the assessment. This includes testing for: genotoxicity, carcinogenicity, safety pharmacology, general toxicity and reproductive toxicity. To support the assessment, knowledge about ADME (absorption, distribution, metabolism, excretion) in relevant species is required so these aspects also are a part of the Non-Clinical Safety test battery. Studies to elucidate the mechanism of the changes seen in the target organ/tissue will also be discussed. Rationalizations of assessment experiments will be described as well as an outline of future trends.

After introduction to factual rules, methodologies and data, participants will be presented with case stories, which they have to evaluate, discuss and finally give recommendation upon in plenum.

Learning Outcome
Non-clinical safety assessment of a potential pharmaceutical represents an important part of the drug development process. Due to the recent 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 applied nowadays. This 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:


Knowledge

  • 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.
  • Provide information on regulatory requirements for studies used in non-clinical safety assessment and the content of application to the authorities.
  • Recall in vivo reproduction in toxicology.


Skills

  • Demonstrate insight and understanding of the requirements for non-clinical safety assessment in vivo as well as in vitro.
  • Identify organ/tissue for the toxicity process.
  • Devise in vitro genotoxicity tests.
  • Select relevant species for carcinogenicity studies in vivo.
  • Provide information on factual guidelines regarding species, methodology and data handling.


Competencies

  • 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 issue in relevant species incl. drug metabolites and toxicokinetics.
  • Integrate the various safety aspects in the overall assessment for selection of drug candidates.
Literature

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.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
It is recommended that the courses Discovery and Development of Medicines and Pharmacology have been passed before joining this course.
The course is organized as an intensive 5-day course comprising lectures in the morning with group discussions on cases, exercises and demonstrations in the afternoon. Exercises are based on case stories where students are presented with toxicological data in a stepwise manner to make their conclusions at each step
  • Category
  • Hours
  • Exam
  • 2
  • Lectures
  • 15
  • Preparation
  • 38
  • Theory exercises
  • 15
  • Total
  • 70
Credit
2,5 ECTS
Type of assessment
Written examination, 2 hours under invigilation
Examination design: The purpose of the examination is to test that the examinee has a broad knowledge and comprehension of non-clinical safety studies and assessment of the findings doing drug development. The test is composed of 1 case problem and of 10 independent descriptive questions. The case problem will represent 60 % of the test; the multiple choice questions will represent 40%.
The percentage of items on the test devoted to a particular topic will roughly correspond to the emphasis given the topic in teaching of the course, and as implied in the general course objectives.
• Regular framework: 25 %
• Acute toxicity testing: 25 %
• Chronic toxicity testing: 25 %
• Genotoxicity, cancerogenicity, reproduction: 25 %
Aid
All aids allowed
Certain pocket calculators are allowed.
Marking scale
7-point grading scale
Censorship form
External censorship
Exam period
Monday 12 May 2014 at 2-4 pm.
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.