SMIMB1041U Pharmacology

Volume 2017/2018
Education

Master's Programme in Industrial Drug Development - compulsory

The course is intended for drug development professionals who need knowledge about basic pharmacological concepts or 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 continuously throughout the lifespan of a drug candidate. Thus, 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 throughout clinical development. The classical disciplines of 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 vitro pharmacology, 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 vitro models
    • its in vivo models
    • its experimental tools
  • identify basic pharmacokinetic parameters
  • identify ADMET and 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 vitro methods
  • 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
We recommend that applicants are familiar with linear and non-linear regression using MS Excel
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

In addition to 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 be allowed to bring a USB stick (for notes etc.)

Calculators are allowed.

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

To be announced at the MIND programme's webpage

Re-exam

To be announced at the MIND programme's webpage

Criteria for exam assesment

The grade 12 is given when the examinee:

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 vitro models
    • its in vivo models
    • its experimental tools
  • identify basic pharmacokinetic parameters
  • identify ADMET and 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 vitro methods
  • 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