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Klinisk läkemedelsutveckling (uppdragsutbildning)
Reading list valid from autumn 2018. Retrieved from uu.se 2 Nov 2026. View the original on uu.se
The latest list is from autumn 2018 and may be out of date. Check with the course before buying.
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Required reading
KLINISKA PRÖVNINGAR - OBLIGATORISK LITTERATUR
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
World Medical Association
Not a book to buy
As written on the list
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/
ICH Topic E3: Structure and Content och Clinical Study Reports
EMA
Not a book to buy
As written on the list
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.pdf
ICH Topic E4: Dose-Response Information to Support Drug Registration
EMA
Not a book to buy
As written on the list
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.pdf
ICH Topic E6: Guideline for Good Clinical Practice
EMA
Not a book to buy
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ICH Topic E6: Guideline for Good Clinical Practice, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
ICH Topic E8: General Considerations for Clinical Trials
EMA
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ICH Topic E8: General Considerations for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002877.pdf
ICH topic E9: Statistical Principles for Clinical Trials
EMA
Not a book to buy
As written on the list
ICH topic E9: Statistical Principles for Clinical Trials, EMA, http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002928.pdf
ICH topic E10: Choice of Control Group and Related Issues in Clinical Trials
EMA
Not a book to buy
As written on the list
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.pdf
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
Not a book to buy
As written on the list
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:32014R0536
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
Not a book to buy
As written on the list
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_en
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
Not a book to buy
As written on the list
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)
Consort 2010 Checklist, Explanations and Elaboration document
2010, The CONSORT Group
Not a book to buy
Klicka på fliken CONSORT 2010 -> CONSORT Checklist för en lättnavigerad webbversion av checklistan med förklaringar.
As written on the list
Consort 2010 Checklist, Explanations and Elaboration document, The CONSORT Group, 2010, CONSORT hemsida (Klicka på fliken CONSORT 2010 -> CONSORT Checklist för en lättnavigerad webbversion av checklistan med förklaringar.)
CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
2010, BMJ
Not a book to buy
open access
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CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials, BMJ, 2010, Artikel med checklista, förklaringar och bakgrund (open access)
Other reading (not marked as required)
KLINISKA PRÖVNINGAR - OBLIGATORISK LITTERATUR › KLINISKA PRÖVNINGAR - REKOMMENDERAD LITTERATUR
Fundamentals of Clinical Trials
Friedman, Lawrence M. m.fl.
5th ed. 2015., 2015, Springer International Publishing
ISBN 9783319185392, e-book
Verified edition
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Friedman, Lawrence M. m.fl., Fundamentals of Clinical Trials, 5th ed. 2015., Cham, Springer International Publishing, 2015
Fundamentals of clinical trials
Friedman, Lawrence M., Furberg, Curt C., DeMets, David L.
Fourth., 2010, Springer New York
ISBN 9781441915863, e-book
Verified edition
Store links are for the print edition (ISBN 9781441915856).
As written on the list
Friedman, Lawrence M.; Furberg, Curt C.; DeMets, David L., Fundamentals of clinical trials, 4. ed., New York, Springer, cop. 2010
Handbok för kliniska prövare
Lemne, Carola, Lafolie, Pierre
6. uppl., 2009, Studentlitteratur
ISBN 9789144056142, print
Verified edition
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Lemne, Carola; Lafolie, Pierre, Handbok för kliniska prövare, 6:1, Studentlitteratur, 2009
Handbok i genomförande av en klinisk prövning: praktisk tillämpning av lagar och regler med fokus på monitering
Anehus, Siw m.fl.
1. uppl., 2012, Studentlitteratur
ISBN 9789144058696, print
Likely edition
As written on the list
Anehus, Siw m.fl., Handbok i genomförande av en klinisk prövning: praktisk tillämpning av lagar och regler med fokus på monitering, 1. uppl., Lund, Studentlitteratur AB, 2012
A Manager's Guide to the Design and Conduct of Clinical Trials, 2nd Edition
Good, Phillip I.
2 uppl., 2006, John Wiley & Sons
ISBN 9780471788706, print
Verified edition
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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: A comprehensive Review and Assessment
Spilker, Bert
2009, Wolters Kluwer/Lippincott Williams & Wilkins Health
ISBN 9780781774246, print
Verified edition
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Spilker, Bert, Guide to Drug Development: A comprehensive Review and Assessment, Philadelphia, Wolters Kluwer/Lippincott Williams & Wilkins Health, 2009
Randomiserade kontrollerade kliniska prövningar: en handledning för den som tar del av prövningsresultatet
Jadad, Alejandro
2000, Studentlitteratur
ISBN 9789144015781, print
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Jadad, Alejandro, Randomiserade kontrollerade kliniska prövningar: en handledning för den som tar del av prövningsresultatet, Lund, Studentlitteratur, 2000
How to write a successful application to a research ethics committee
Lafolie, Pierre
2006, Karolinska Institutet University Press
ISBN 9789185565009, print
Verified edition
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Lafolie, Pierre, How to write a successful application to a research ethics committee, Stockholm, Karolinska Institutet University Press, 2006
Handbook of phase I/II clinical drug trials
O'Grady, John, Joubert, Pieter H.
[New ed.], 1997, CRC Press
ISBN 9780849392306, print
Verified edition
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O'Grady, John; Joubert, Pieter H., Handbook of phase I/II clinical drug trials, [New ed.], Boca Raton, CRC Press, c1997
FDA Regulatory Affairs
Pisano, Douglas J., Mantus, David S.
3. ed., 2014, Taylor & Francis Ltd
ISBN 9781841849195, print
Verified edition
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Pisano, Douglas J.; Mantus, David S., FDA Regulatory Affairs, 3. ed., New York, Taylor & Francis Ltd, 2014
Clinical trials: a practical approach
Pocock, Stuart J.
1983, Wiley
ISBN 9780471901556, print
Verified edition
En gammal klassiker, där mycket klokt finns samlat och som vi ofta slår i
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Pocock, Stuart J., Clinical trials: a practical approach, Chichester, Wiley, cop. 1983 (En gammal klassiker, där mycket klokt finns samlat och som vi ofta slår i)
LVFS 2011:19 Läkemedelsverkets föreskrifter om kliniska läkemedelsprövningar på människor
Rångemark Åkerman, Christina
2011, Läkemedelsverket
Not a book to buy
As written on the list
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
2013, Läkemedelsverket
Not a book to buy
As written on the list
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
KLINISKA PRÖVNINGAR - OBLIGATORISK LITTERATUR › STATISTIK - REKOMMENDERAD LITTERATUR
Medical statistics: a textbook for the health sciences
Machin, David, Campbell, Michael J., Walters, Stephen John
4th ed., 2007, Wiley
ISBN 9780470976630, e-book
Verified edition
Store links are for the print edition (ISBN 9780470025192).
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Machin, David; Campbell, Michael J.; Walters, Stephen John, Medical statistics: a textbook for the health sciences, 4th ed., Chichester, Wiley, 2007
Introduktion till medicinsk statistik
Bring, Johan, Taube, Adam
2006, Studentlitteratur
ISBN 9789144037486, print
Verified edition
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Bring, Johan; Taube, Adam, Introduktion till medicinsk statistik, Lund, Studentlitteratur, 2006
Statistisk dataanalys
Körner, Svante, Wahlgren, Lars
4., [omarb.] uppl., 2006, Studentlitteratur
ISBN 9789144015736, print
Verified edition
A newer edition exists (2015), ISBN 9789144108704. Check with the course which one applies.
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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
Not a book to buy
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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
Not a book to buy
As written on the list
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
Not a book to buy
As written on the list
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
Medical statistics at a glance
Petrie, Aviva, Sabin, Caroline
3. ed., 2009, Wiley-Blackwell
ISBN 9781405180511, print
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Petrie, Aviva; Sabin, Caroline, Medical statistics at a glance, 3. ed., Malden, Mass., Wiley-Blackwell, 2009
Clinical trials: a methodologic perspective
Piantadosi, Steven
2. ed., 2005, Wiley
ISBN 9780471727811, print
Verified edition
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Piantadosi, Steven, Clinical trials: a methodologic perspective, 2. ed., Hoboken, N.J., Wiley, 2005
Clinical trials: a methodologic perspective
Piantadosi, Steven.
2nd ed., 2005, Wiley-Interscience
ISBN 9780471740131, e-book
Verified edition
Store links are for the print edition (ISBN 9780471727811).
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Piantadosi, Steven., Clinical trials: a methodologic perspective, 2nd ed., Hoboken, N.J., Wiley-Interscience, c2005
KLINISKA PRÖVNINGAR - OBLIGATORISK LITTERATUR › FARMAKOLOGI - REKOMMENDERAD LITTERATUR
Medical pharmacology at a glance
Neal, M. J.
7th ed., 2012, John Wiley & Sons
ISBN 9781118306468, e-book
Verified edition
Store links are for the print edition (ISBN 9780470657898).
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Neal, M. J., Medical pharmacology at a glance, 7th ed., Hoboken, John Wiley & Sons, 2012
Medical Pharmacology at a Glance, 8th Edition
Neal, Michael J.
8., [updated] ed., 2016, Wiley-Blackwell
ISBN 9781118902400, print
Verified edition
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Neal, Michael J., Medical Pharmacology at a Glance, 8th Edition, John Wiley & Sons, 2015
Introduction to pharmacokinetics and pharmacodynamics: the quantitative basis of drug therapy
Tozer, Thomas N., Rowland, Malcolm.
2006, Lippincott Williams & Wilkins
ISBN 9780781751490, print
Verified edition
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Tozer, Thomas N.; Rowland, Malcolm., Introduction to pharmacokinetics and pharmacodynamics: the quantitative basis of drug therapy, Philadelphia, Lippincott Williams & Wilkins, cop. 2006
KLINISKA PRÖVNINGAR - OBLIGATORISK LITTERATUR › FARMAKOKINETIK - REKOMMENDERAD LITTERATUR
Pocket guide: pharmacokinetics made easy
Birkett, D. J.
2nd ed., 2010, McGraw-Hill Australia
ISBN 9780070285279, print
Verified edition
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Birkett, D. J., Pocket guide: pharmacokinetics made easy, 2nd ed., North Ryde, N.S.W., McGraw-Hill Australia, 2010
Clinical pharmacokinetics and pharmacodynamics: concepts and applications
Rowland, Malcolm, Tozer, Thomas N., Rowland, Malcolm.
4th ed., 2011, Wolters Kluwer Health/Lippincott William & Wilkins
ISBN 9780781750097, print
Verified edition
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Rowland, Malcolm; Tozer, Thomas N.; Rowland, Malcolm., Clinical pharmacokinetics and pharmacodynamics: concepts and applications, 4th ed., Philadelphia, Wolters Kluwer Health/Lippincott William & Wilkins, c2011
DIVERSE LÄKEMEDELSUTVECKLING › DIVERSE LÄKEMEDELSUTVECKLING
Innovation in the pharmaceutical industry: the process of drug discovery and development
Hara, Takuji
2003, Edward Elgar
ISBN 9781843760504, print
Verified edition
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Hara, Takuji, Innovation in the pharmaceutical industry: the process of drug discovery and development, Cheltenham, Edward Elgar, cop. 2003
The billion-dollar molecule: one company's quest for the perfect drug
Werth, Barry
1994, Simon & Schuster
ISBN 9780671723279, print
Verified edition
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Werth, Barry, The billion-dollar molecule: one company's quest for the perfect drug, New York, Simon & Schuster, cop. 1994
Over dose: the case against the drug companies: prescription drugs, side effects, and your health
Cohen, Jay S
2001, Jeremy P Tarcher/Putnam
ISBN 9781585421237, print
Verified edition
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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
Health economics: an introduction to economic evaluation
Kobelt, Gisela
2. ed., 2002, Office of Health Economics
ISBN 9781899040223, print
Verified edition
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Kobelt, Gisela, Health economics: an introduction to economic evaluation, 2. ed., London, Office of Health Economics, cop. 2002
LÄKEMEDELSHISTORISKA MILSTOLPAR › LÄKEMEDELSHISTORISKA MILSTOLPAR
Nya skapelser: Losec-entreprenörens recept
Östholm, Ivan
1996, Fischer
ISBN 9789170548178, print
Verified edition
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Östholm, Ivan, Nya skapelser: Losec-entreprenörens recept, Stockholm, Fischer, 1996
The first miracle drugs: how the sulfa drugs transformed medicine
Lesch, John E.
2007, Oxford University Press
ISBN 9780195187755, print
Verified edition
En "eye-opener". Mycket intressant hände faktiskt före penicillinet.
As written on the list
Lesch, John E., The first miracle drugs: how the sulfa drugs transformed medicine, New York, Oxford University Press, cc2007 (En "eye-opener". Mycket intressant hände faktiskt före penicillinet.)
The Rise and Fall of Modern Medicine
Le Fanu, Fanu
2011, Little, Brown Book Group
ISBN 9780349123752, print
Verified edition
1:a halvan av boken är en underbar beskrivning av medicinhistoriens stora ögonblick. Den börjar med penicillinet och kortisonet och slutar med första provrörsbarnet och magsårsbakterien. Andra halvan beskriver "the Fall" = genetik och epidemiologi.
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Le Fanu, Fanu, The Rise and Fall of Modern Medicine, Little, Brown Book Group, 2011 (1:a halvan av boken är en underbar beskrivning av medicinhistoriens stora ögonblick. Den börjar med penicillinet och kortisonet och slutar med första provrörsbarnet och magsårsbakterien. Andra halvan beskriver "the Fall" = genetik och epidemiologi.)
Historier om läkemedel: om genialitet, hugskott, slump och vardagsslit
Ajanki, Tord, Prah, André
1995, Apotekarsocieteten
ISBN 9789186274603, print
Verified edition
Korta underhållande läkemedelshistorier - från Jenners vaccin till Bantings insulin
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Ajanki, Tord; Prah, André, Historier om läkemedel: om genialitet, hugskott, slump och vardagsslit, Stockholm, Apotekarsocieteten, 1995 (Korta underhållande läkemedelshistorier - från Jenners vaccin till Bantings insulin)
Läkemedel som förändrat världen: historier om vetenskap, slump och envishet
Wennerberg, Johan
2012, Apotekarsocieteten
ISBN 9789197945257, print
Verified edition
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Wennerberg, Johan, Läkemedel som förändrat världen: historier om vetenskap, slump och envishet, Stockholm, Apotekarsocieteten, 2012
Pillret: en berättelse om depressioner och doktorer, forskare och Freud, människor och marknader
Carlberg, Ingrid
Pocketutg., 2011, Norstedt
ISBN 9789113037936, print
Verified edition
Nominerad till Augustpriset 2008. Den berättar om SSRI-preparatens historia inklusive företagens knep och marknadsspelet om läkemedelsmiljarderna.
As written on the list
Carlberg, Ingrid, Pillret: en berättelse om depressioner och doktorer, forskare och Freud, människor och marknader, Pocketutg., Stockholm, Norstedt, 2011 (Nominerad till Augustpriset 2008. Den berättar om SSRI-preparatens historia inklusive företagens knep och marknadsspelet om läkemedelsmiljarderna.)
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