Syllabus for Clinical Drug Development

Klinisk läkemedelsutveckling

Syllabus

  • 30 credits
  • Course code: 3KK005
  • Education cycle: Second cycle
  • Main field(s) of study and in-depth level: Medical Science A1N, Biomedicine A1N

    Explanation of codes

    The code indicates the education cycle and in-depth level of the course in relation to other courses within the same main field of study according to the requirements for general degrees:

    First cycle
    G1N: has only upper-secondary level entry requirements
    G1F: has less than 60 credits in first-cycle course/s as entry requirements
    G1E: contains specially designed degree project for Higher Education Diploma
    G2F: has at least 60 credits in first-cycle course/s as entry requirements
    G2E: has at least 60 credits in first-cycle course/s as entry requirements, contains degree project for Bachelor of Arts/Bachelor of Science
    GXX: in-depth level of the course cannot be classified.

    Second cycle
    A1N: has only first-cycle course/s as entry requirements
    A1F: has second-cycle course/s as entry requirements
    A1E: contains degree project for Master of Arts/Master of Science (60 credits)
    A2E: contains degree project for Master of Arts/Master of Science (120 credits)
    AXX: in-depth level of the course cannot be classified.

  • Grading system: Fail (U), Pass (G)
  • Established: 2009-04-29
  • Established by:
  • Revised: 2019-03-05
  • Revised by: The Educational Board of Medicine
  • Applies from: week 27, 2019
  • Entry requirements: At least 180 credits within the disciplinary domains of Medicine and Pharmacy.
  • Responsible department: Department of Medical Sciences

Learning outcomes

This course aims to provide students with a broad and deep knowledge of most stages in a drug's development from idea to completed product. Special emphasis is placed on clinical trial methodology, where the students will learn to plan a larger clinical trial.
At the end of the course the students should:
- Be able to describe the basic principles of pharmacokinetics (PK) and the most common types of PK studies as well as be able to do calculations using pharmacokinetic formulas
- Be able to describe clinical trial methodology according to Good Clinical Practice (GCP)
- Be able to describe the basic principles of biostatistics in clinical trials and do sample size calculations
- Be familiar with the regulatory procedures for the registration of new drugs and the other roles of Regulatory
Affairs in clinical drug development
- Be able to describe the purpose of clinical trial monitoring and be able to perform the monitoring of a clinical trial
- Be able to write a complete clinical trial protocol

Content

The course consists of the following sections:

Introduction and ethics in clinical trials
Pharmacokinetics, PK/PD
Pre-clinical drug development and toxicology
Basic statistics for clinical trials
Trial methodology with applied biostatistics
Registration of new drugs - Regulatory affairs
Clinical trials in various diagnostic areas
Monitoring
Protocol writing

Instruction

The course is given as a series of lectures and seminars, but also consists of study visits, individual projects, and group assignments.

Assessment

Examinations are arranged continuously as seminars or written examinations.

At the final exam, the students will write a complete clinical trial protocol and present it before a smaller group of students as well as examiners in a respondent/opponent form

Students who have not passed the examination have the right to take the examination 4 additional times (= total of 5 examinations). If the student can claim special reasons, additional examinations may be allowed. Every time the student actually sits for an examination will be counted as an examination. Submission of so-called blank examination is counted as an examination.

If there are special reasons for doing so, an examiner may make an exception from the method of assessment indicated and allow a student to be assessed by another method. An example of special reasons might be a certificate regarding special pedagogical support from the University´s disability coordinator.

Reading list

Reading list

Applies from: week 25, 2019

CLINICAL TRIALS - MANDATORY LITERATURE

CLINICAL TRIALS RECOMMENDED LITERATURE

  • Fundamentals of Clinical Trials Friedman, Lawrence M.; Furberg, Curt D.; DeMets, David L.; Reboussin, David M.; Granger, Christopher B.

    5th ed. 2015.: Cham: Springer International Publishing, 2015.

    Table of Contents / Abstracts

    Find in the library

  • Friedman, Lawrence M.; Furberg, Curt C.; DeMets, David L. Fundamentals of clinical trials

    4. ed.: New York: Springer, cop. 2010

    Find in the library

  • Lemne, Carola; Lafolie, Pierre Handbok för kliniska prövare

    6:1: Studentlitteratur, 2009

    Find in the library

  • Handbok i genomförande av en klinisk prövning : praktisk tillämpning av lagar och regler med fokus på monitering Anehus, Siw; Lindberg, Niklas; Lomberg, Helena; Svensson, Margareta; Wiebols, Maria Öman, Aina

    1. uppl.: Lund: Studentlitteratur AB, 2012

    Find in the library

  • Good, Phillip I. A Manager's Guide to the Design and Conduct of Clinical Trials, 2nd Edition

    2. uppl.: John Wiley & Sons, 2006

    Find in the library

  • Spilker, Bert Guide to Drug Development : A comprehensive Review and Assessment

    Philadelphia: Wolters Kluwer/Lippincott Williams & Wilkins Health, 2009

    Find in the library

  • Jadad, Alejandro Randomiserade kontrollerade kliniska prövningar : en handledning för den som tar del av prövningsresultatet

    Lund: Studentlitteratur, 2000

    Find in the library

  • Lafolie, Pierre How to write a successful application to a research ethics committee

    Stockholm: Karolinska Institutet University Press, 2006

    Find in the library

  • O'Grady, John; Joubert, Pieter H. Handbook of phase I/II clinical drug trials

    [New ed.]: Boca Raton: CRC Press, c1997

    Find in the library

  • Pisano, Douglas J.; Mantus, David S. FDA Regulatory Affairs

    3. ed.: New York: Taylor & Francis Ltd, 2014

    Find in the library

  • Pocock, Stuart J. Clinical trials : a practical approach

    Chichester: Wiley, cop. 1983

    A classic book with lots of sensible information which we often use.

    Find in the library

  • Rångemark Åkerman, Christina LVFS 2011:19 Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor

    Läkemedelsverket, 2011

    https://lakemedelsverket.se/upload/lvfs/LVFS_2011_19.pdf

  • litteratur Vägledning (version 2) till Läkemedelsverkets föreskrifter (LVFS 2011:19) om kliniska läkemedelsprövningar på människor

    Läkemedelsverket, 2013

    https://lakemedelsverket.se/upload/lvfs/vagledningar/V%C3%A4gledning_LVFS_2011-19_v2.pdf

STATISTICS - RECOMMENDED LITTERATURE

PHARMACOLOGY - RECOMMENDED LITERATURE

  • Neal, M. J. Medical pharmacology at a glance

    7th ed.: Hoboken: John Wiley & Sons, 2012

    Find in the library

  • Neal, Michael J. Medical Pharmacology at a Glance, 8th Edition

    John Wiley & Sons, 2015

    Find in the library

  • Tozer, Thomas N.; Rowland, Malcolm. Introduction to pharmacokinetics and pharmacodynamics : the quantitative basis of drug therapy

    Philadelphia: Lippincott Williams & Wilkins, cop. 2006

    Find in the library

PHARMACOKINETICS - RECOMMENDED LITTERATURE

  • Birkett, D. J. Pocket guide : pharmacokinetics made easy

    2nd ed.: North Ryde, N.S.W.: McGraw-Hill Australia, 2010

    Find in the library

  • Rowland, Malcolm; Tozer, Thomas N.; Rowland, Malcolm. Clinical pharmacokinetics and pharmacodynamics : concepts and applications

    4th ed.: Philadelphia: Wolters Kluwer Health/Lippincott William & Wilkins, c2011

    Find in the library

GENERAL BOOKS ON DRUG DEVELOPMENT

GENERAL BOOKS ON DRUG DEVELOPMENT

  • Hara, Takuji Innovation in the pharmaceutical industry : the process of drug discovery and development

    Cheltenham: Edward Elgar, cop. 2003

    Find in the library

  • Werth, Barry The billion-dollar molecule : one company's quest for the perfect drug

    New York: Simon & Schuster, cop. 1994

    Find in the library

  • Cohen, Jay S Over dose : the case against the drug companies : prescription drugs, side effects, and your health

    New York: Jeremy P Tarcher/Putnam, c2001

    Find in the library

  • Kobelt, Gisela Health economics : an introduction to economic evaluation

    2. ed.: London: Office of Health Economics, cop. 2002

    Find in the library

MILESTONES IN DRUG DEVELPMENT HISTORY

MILESTONES IN DRUG DEVELOPMENT HISTORY

  • Östholm, Ivan Eliasson, Gunnar Nya skapelser : Losec-entreprenörens recept

    Stockholm: Fischer, 1996

    Find in the library

  • Lesch, John E. The first miracle drugs : how the sulfa drugs transformed medicine

    New York: Oxford University Press, cc2007

    Find in the library

  • Le Fanu, Fanu The Rise and Fall of Modern Medicine

    Little, Brown Book Group, 2011

    Find in the library

  • Ajanki, Tord; Prah, André Historier om läkemedel : om genialitet, hugskott, slump och vardagsslit

    Stockholm: Apotekarsocieteten, 1995

    Short entertaining drug discovery stories - from Jenner's vaccine to Banting's insuline

    Find in the library

  • Wennerberg, Johan Läkemedel som förändrat världen : historier om vetenskap, slump och envishet

    Stockholm: Apotekarsocieteten, 2012

    Find in the library

  • Carlberg, Ingrid Pillret : en berättelse om depressioner och doktorer, forskare och Freud, människor och marknader

    Pocketutg.: Stockholm: Norstedt, 2011

    Find in the library

Health Economics