Clinical trials and statistics - mandatory literature

• Anehus, Siw et al., Handbok i genomförande av en klinisk prövning: praktisk tillämpning av lagar och regler med fokus på monitering, 1. uppl., Lund, Studentlitteratur AB, 2012Compulsory*
• Bring, Johan; Taube, Adam; Wikman, Per, Introduktion till medicinsk statistik, 2., utök. uppl., Lund, Studentlitteratur, 2015Compulsory*
• WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, WebbsidaCompulsory*
• ICH Topic E3: Structure and Content och Clinical Study Reports, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002832.pdfCompulsory*
• ICH Topic E4: Dose-Response Information to Support Drug Registration, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002834.pdfCompulsory*
• ICH Topic E6: Guideline for Good Clinical Practice, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdfCompulsory*
• ICH Topic E8: General Considerations for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002877.pdfCompulsory*
• ICH topic E9: Statistical Principles for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdfCompulsory*
• ICH topic E10: Choice of Control Group and Related Issues in Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002925.pdfCompulsory*
• LVFS 2011:19 Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor, Part of: Läkemedelsverkets författningssamling: LVFSCompulsory*
• Vägledning (version 2) till Läkemedelsverkets föreskrifter (LVFS 2011:19) om kliniska läkemedelsprövningar på människor, Läkemedelsverket, http://www.lakemedelsverket.se/upload/lvfs/vagledningar/V%C3%A4gledning_LVFS_2011-19_v2.pdfCompulsory*
• DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for hum, EU, http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2001:121:0034:0044:SV:PDFCompulsory*
• REGULATION No 536/2014 of the European Parliament and of the Council on clinical trials on medicinal products for human use, repealing Directive 2001/20/EC., EU, länk
• 2011/C 172/01: Communication from the Commission — Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use ('CT-3'), EU, länkCompulsory*
• Consort 2010 Checklist, Explanations and Elaboration document, The CONSORT Group, 2010, CONSORT hemsidaCompulsory*
• CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, BMJ, 2010, Artikel med checklista, förklaringar och bakgrund (open access)Compulsory*

Clinical trials and statistics - recommended literature

• Lemne, Carola; Lafolie, Pierre, Handbok för kliniska prövare, 6:1, Studentlitteratur, 2009
• Friedman, Lawrence M.; Furberg, Curt C.; DeMets, David L., Fundamentals of clinical trials, 4. ed., New York, Springer, cop. 2010
• Good, Phillip I., A Managers' Guide to the Design and Conduct of Clinical Trials, Hoboken, John Wiley & Sons, Inc., 2006
• Good, Phillip I., A Manager's Guide to the Design and Conduct of Clinical Trials, 2nd Edition, 2. uppl., John Wiley & Sons, 2006
• Guide to Drug Development, Philadelphia, Wolters Kluwer/Lippincott Williams & Wilkins Health, 2009
• Jadad, Alejandro, Randomiserade kontrollerade kliniska prövningar: en handledning för den som tar del av prövningsresultatet, Lund, Studentlitteratur, 2000
• Lafolie, Pierre, How to write a successful application to a research ethics committee, Stockholm, Karolinska Institutet University Press, 2006
• O'Grady, John; Joubert, Pieter H., Handbook of phase I/II clinical drug trials, [New ed.], Boca Raton, CRC Press, c1997
• Pisano, Douglas J.; Mantus, David, FDA regulatory affairs, Third edition., Boca Raton, CRC Press, [2014]
• Pisano, Douglas J.; Mantus, David S., FDA Regulatory Affairs, 3. ed., New York, Taylor & Francis Ltd, 2014
• Pocock, Stuart J., Clinical trials: a practical approach, Chichester, Wiley, cop. 1983 (A classic book with lots of sensible information which we often use.)

Pharmacology - Recommended literature

• Neal, M. J., Medical pharmacology at a glance, 7th ed., Hoboken, John Wiley & Sons, 2012
• Neal, Michael J., Medical Pharmacology at a Glance, 8th Edition, John Wiley & Sons, 2015
• Tozer, Thomas N.; Rowland, Malcolm., Introduction to pharmacokinetics and pharmacodynamics: the quantitative basis of drug therapy, Philadelphia, Lippincott Williams & Wilkins, cop. 2006

Pharmacokinetics - recommended literature

• Birkett, D. J., Pocket guide: pharmacokinetics made easy, 2nd ed., North Ryde, N.S.W., McGraw-Hill Australia, 2010
• Rowland, Malcolm; Tozer, Thomas N.; Rowland, Malcolm., Clinical pharmacokinetics and pharmacodynamics: concepts and applications, 4th ed., Philadelphia, Wolters Kluwer Health/Lippincott William & Wilkins, c2011

Statistics - recommended literature

• CPMP/EWP/908/99: POINTS TO CONSIDER ON MULTIPLICITY ISSUES IN CLINICAL TRIALS, EMA, European Medicines Agency, http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003640.pdf
• EMA/CPMP/EWP/1776/99 Rev. 1: Guideline on Missing Data in Confirmatory Clinical Trials, EMA, European Medicines Agency, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/09/WC500096793.pdf
• CPMP/EWP/482/99: POINTS TO CONSIDER ON SWITCHING BETWEEN SUPERIORITY AND NON-INFERIORITY, EMA, European Medicines Agency, http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003658.pdf
• Petrie, Aviva; Sabin, Caroline, Medical statistics at a glance, 3. ed., Malden, Mass., Wiley-Blackwell, 2009
• Piantadosi, Steven, Clinical trials: a methodologic perspective, New York, Wiley, cop. 1997

Main group 2

• Innovation in the Pharmaceutical Industry, 2003
• Hara, Takuji, Innovation in the pharmaceutical industry: the process of drug discovery and development, Cheltenham, Edward Elgar, cop. 2003
• Werth, Barry, The billion-dollar molecule: one company's quest for the perfect drug, New York, Simon & Schuster, cop. 1994
• 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
• Kobelt, Gisela, Health economics: an introduction to economic evaluation, 2. ed., London, Office of Health Economics, cop. 2002

Main group 3

• Östholm, Ivan, Nya skapelser: Losec-entreprenörens recept, Stockholm, Fischer, 1996
• Lesch, John E., The first miracle drugs: how the sulfa drugs transformed medicine, New York, Oxford University Press, cc2007
• Le Fanu, Fanu, The Rise and Fall of Modern Medicine, Little, Brown Book Group, 2011
• 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)
• Wennerberg, Johan, Läkemedel som förändrat världen: historier om vetenskap, slump och envishet, Stockholm, Apotekarsocieteten, 2012
• Carlberg, Ingrid, Pillret: en berättelse om depressioner och doktorer, forskare och Freud, människor och marknader, Pocketutg., Stockholm, Norstedt, 2011

* Compulsory