SMIMB1041U Pharmacology

Volume 2014/2015
Education

Please note this is course description is for the study year 2014/2015. For updated information on dates, prices etc. in other semesters please visit www.mind.ku.dk.

This course is a compulsory course at the Master's Programme in Industrial Drug Development.

The course is intended for drug development professionals who need knowledge about basic pharmacological concepts and other drug developers and professionals who need a brush-up course on pharmacology for continuing professional development (CPD).

Master’s level (second cycle higher education). Open for freelance students who meet the admission criteria. Compulsory for MIND students, elective for other part-time master's students. (subject to study board approval).

Content

The pharmacological concepts, methodologies and techniques are fundamental for modern drug development. As a discipline it does not fit in for one particular part of the drug development process. Instead it is applied at many occasions in the lifespan of a drug candidate. In this connection basic pharmacological knowledge is important for those who want to possess an integrated view on the effects and behaviour of the drug candidate from discovery to clinical development. The classical disciplines concerning pharmacodynamics and pharmacokinetics are addressed separately to be familiar with the theoretical background behind these disciplines. Pharmacology also bridges the preclinical phase with clinical trials and thus is central in the translation of animal data to the human situation.

The course will teach the basic concepts of general pharmacology. Emphasis is on pharmacokinetics with hands-on calculations. It runs over two days and is computer aided. There is focus on experimental in vitro and in vivo tools and on animal experimental models for various diseases including modern experimental techniques.

The course covers the following areas:

  • General pharmacology (pharmacodynamics)
  • Pharmacokinetics (basic concepts, extra vascular dosing using a one-compartment model, IV administration using 1- and 2 compartment models, elimination: metabolism and excretion, hands-on calculation in an Excel spreadsheet)
  • Exploratory pharmacology (measurement of pharmacological effect, safety pharmacology)
  • In vitropharmacology, concepts and methodology (ADME; biomarkers; metabolism; transporters)
  • In vivo pharmacology, methodology (animal models for cardiovascular diseases, obesity, bone and joint diseases and pain; behavioural animal models.)
Learning Outcome

Upon completion of the course, participants are expected to be able to:

Knowledge

  • pin-point the role of pharmacology in the drug development process
  • demonstrate basic knowledge of pharmacology
    • its basic concepts regarding PD and PK
    • its in vitromodels
    • its in vivomodels
    • its experimental tools
  • identify basic pharmacokinetic parameters
  • identify safety pharmacology aspects

Skills

  • interpret raw pharmacodynamic data sets
  • calculate and interpret raw pharmacokinetic data sets
  • rank compounds delivered from discovery for further handling in development
  • conduct validation applied in in vitromethods
  • conduct validation applied in in vivo methods

Competencies

  • integrate a pharmacology perspective in the planning of the various stages of the drug development process
  • handle translational aspects in a pharmacological perspective
  • communicate professionally using pharmacology terminology

The syllabus comprises collections of review papers, textbook chapters, case stories and hand-outs from course presentations, in total approximately 250 pages.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
Lectures in the morning. Problem solving and cases (group work) in the afternoon. Afternoon sessions concern pharmacokinetic and pharmacodynamic problem solving, construction of own disease model and biomarker selection. Hands-on pharmacokinetics with computer simulation.
  • Category
  • Hours
  • Class Instruction
  • 35
  • Exam
  • 2
  • Exam Preparation
  • 8
  • Preparation
  • 23,75
  • Total
  • 68,75
Credit
2,5 ECTS
Type of assessment
Written examination, 2 under invigilation
Problems based on a case description, supplemented with multiple choice and short essay questions.
Aid
Written aids allowed

Apart from the standard programs and IT tools listed under The Faculty of Health and Medical Sciences at http://pc-eksamen.ku.dk/pc_exam students will at this exam also have access to use a USB stick (for notes etc.)

Calculators are not allowed.

Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

Exam on the last day of the course 11 May 2015 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 in non-clinical pharmacological characterization in the development process of a new chemical entity

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 in non-clinical pharmacological characterization in the development process of a new chemical entity

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 a limited extent and with a number of deficits capability to handle relevant terms, principles and methods used in non-clinical pharmacological characterization in the development process of a new chemical entity