CLINICAL TRIALS - MANDATORY LITERATURE

• WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects, World Medical Association, https://www.wma.net/what-we-do/medical-ethics/declaration-of-helsinki/Compulsory*
• 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*
• 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, http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1497947926249&uri=CELEX:32014R0536Compulsory*
• DIRECTIVE 2001/20/E, 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 human use, EU, https://ec.europa.eu/health/human-use/clinical-trials/directive_enCompulsory*
• 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, http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1497948126522&uri=CELEX:52011XC0611(01)Compulsory*
• Consort 2010 Checklist, Explanations and Elaboration document, The CONSORT Group, 2010, CONSORT hemsidaCompulsory* (Click on CONSORT 2017 - CONSORT Checklist for the web version of the chekclist with explanations)
• 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 RECOMMENDED LITERATURE

• Friedman, Lawrence M. et al., Fundamentals of Clinical Trials, 5th ed. 2015., Cham, Springer International Publishing, 2015
• Friedman, Lawrence M.; Furberg, Curt C.; DeMets, David L., Fundamentals of clinical trials, 4. ed., New York, Springer, cop. 2010
• Lemne, Carola; Lafolie, Pierre, Handbok för kliniska prövare, 6:1, Studentlitteratur, 2009
• 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, 2012
• Good, Phillip I., A Manager's Guide to the Design and Conduct of Clinical Trials, 2nd Edition, 2. uppl., John Wiley & Sons, 2006
• Spilker, Bert, Guide to Drug Development: A comprehensive Review and Assessment, 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 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.)
• 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

• Machin, David; Campbell, Michael J.; Walters, Stephen John, Medical statistics: a textbook for the health sciences, 4th ed., Chichester, Wiley, 2007
• Bring, Johan; Taube, Adam, Introduktion till medicinsk statistik, Lund, Studentlitteratur, 2006
• Körner, Svante; Wahlgren, Lars, Statistisk dataanalys, 4:e upplagan, Lund, Studentlitteratur, 2006
• 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, 2. ed., Hoboken, N.J., Wiley, 2005
• Piantadosi, Steven., Clinical trials: a methodologic perspective, 2nd ed., Hoboken, N.J., Wiley-Interscience, c2005

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 LITTERATURE

• 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

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
• 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

MILESTONES IN DRUG DEVELPMENT HISTORY

MILESTONES IN DRUG DEVELOPMENT HISTORY

• 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