Pharmacology

Farmakologi
Course code: FMIMB1041U (previously B-8104)

Course objectives

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.

Target group

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).

Prerequisites

Applicants must meet the following criteria:

• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

For those with little drug development experience it is advised that the introductory course "Discovery and Development of Medicines" should have been passed. Basic pharmacokinetics should be read in beforehand according to a simple basic textbook e.g. D.J. Birkett: Pharmacokinetics Made Easy. McGraw-Hill Companies Inc.

Learning outcomes

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 safety pharmacology aspects chemical compounds

Skills

• calculate and 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.

Contents

The course will teach the basic concepts of general pharmacology. Emphasis is on pharmacokinetics with hands-on calculations. 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.)

Syllabus

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

Teaching methods

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.

Examination and assessment

Type of examination: 2-hour written examination (anonymous).

Examination design: Problems based on a case description, supplemented with multiple choice and short essay questions.

Exam aids: All exam aids are allowed. Certain electronic pocket calculators are allowed.

Examiner(s): Course directors and an external examiner

Grading: According to the 7-point grading scale

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.

Student workload

Preparation: 25 hours
Confrontation: 35 hours
Examination incl. preparation for examination: 10 hours
In total 70 hours

Course directors

Professor Ole J. Bjerrum (MD, DMSc), Department of Pharmacology and Pharmacotherapy, The Faculty of Pharmaceutical Sciences, University of Copenhagen

Associate Professor Anne Marie Heegaard (PhD), Department of Pharmacology and Pharmacotherapy , The Faculty of Pharmaceutical Sciences, University of Copenhagen

Lecturers

List of lecturers may be subject to change.

• Anne-Marie Heegaard, Faculty of Pharmaceutical Sciences
• Bente Steffansen, Faculty of Pharmaceutical Sciences
• Bjarke Ebert, H. Lundbeck
• Darryl Pickering, Faculty of Pharmaceutical Sciences
• Frank Larsen, H. Lundbeck
• Helle Waagepetersen, Faculty of Pharmaceutical Sciences
• Inge de Jong, H. Lundbeck
• Jørgen Olsen, Novo Nordisk
• Kim Kristensen, Novo Nordisk
• Kim Sonne, LEO Pharma
• Lasse Tengbjerg Hansen, Novo Nordisk
• Majid Sheykhzade, Faculty of Pharmaceutical Sciences
• Mette Guldbrandt, Novo Nordisk
• Ole J. Bjerrum, Faculty of Pharmaceutical Sciences
• Peter B. Johansen, Novo Nordisk
• Uffe Kristiansen, Faculty of Pharmaceutical Sciences

Practical information

Status: Master's level (second-cycle). Open for freelance students who meet the admission criteria. Compulsory for MIND students, elective for other part-time master's students at the Faculty of Pharmaceutical Sciences subject to study board approval.

Date: 13-17 May 2013. Examination 27 May 2013.

Application deadline: 1 March 2013.

Course credits: 2.5 ECTS credits = a student workload of approx. 70 hours

Course fee: Part-time master’s students at Faculty of Pharmaceutical Sciences DKK 7,890, freelance students DKK 9,350, freelance students from non-EU/EEA countries DKK 11,290. An additional fee of DKK 1,300 is charged for course materials and lunch. Prices may be subject to change.

Course capacity: 25 participants.

Language of instruction: English

Preliminary course description.