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Clinical Research Manual 2013 - Product Image

Clinical Research Manual 2013

  • Published: June 2013
  • Region: Global
  • Euromed Communications

A practical, regularly updated international handbook for all those working in clinical research.

The editors have a wealth of experience between them of the teaching and practice of clinical research, and have selected and reviewed each chapter to ensure completeness and relevance. The chapters are written by acknowledged experts from companies and organisations involved in every aspect of clinical research, each providing practical advice and information.

A new updated version of the book is published every two years in line with changes in regulations and current practice.

Edited by David Luscombe and Peter D Stonier

CHAPTERS AND AUTHORS

Edited by David Luscombe and Peter D Stonier

1. Drug Discovery
Charles J R Hedgecock
Biovitrum, Sweden

2. The Planning of International
Development of New Medicines
D Michael Humphreys
Boehringer Ingelheim Ltd, UK

3. Pharmacokinetics
Stephen I Ankier
Ankier Associates, UK

4. Product Registration in the UK and
Europe
Janice Kirby-Smith
NDA Regulatory Science Ltd, UK

5. Regulatory Processes in the USA
Thomas L Pituk
Tibotec Inc, USA

6. The Japanese Regulatory System
David Jefferys
EISAI Europe Ltd, UK

7. Ethical and Legal Aspects of Clinical
Research
Arundel McDougal, Camilla Hoffman and
Jo-Anne Powell
Ashurst, UK

8. Monitoring the Safety of Medicines
Ronald D Mann
University of Southampton, UK

9. Study Design
Alan Davies and John Whittaker
Kendle International Inc, UK

10. Recruitment of Investigators
Jacqueline Karmel and Roy Shentall
Millennium Pharmaceuticals Ltd and
Lancashire Teaching Hospitals NHS Trust, UK

11. Clinical Trial Monitoring
Gareth Hayes
Phlexglobal Ltd, UK

12. Good Clinical Research Practice
David Talbot
LEO Pharma, UK

13. Standard Operating Procedures
Pauline Arnott
DAR Ltd, UK

14. Clinical Trial Supplies
Sue Miles
Brecon Pharmaceuticals Ltd, UK

15. Statistics
Anne Wiles and Dennis Chanter
BRI International Ltd, UK

16. Quality Assurance and Clinical
Research
Rita Hattemer-Apostel
Verdandi AG, Switzerland

17. Report Writing
Janet Gough
Documentation, Systems, and Training, USA

18. Socioeconomics in Healthcare
M Sam Salek and Brian B Godman
University of Wales, UK

19. Research Fraud and Misconduct
Jane Barrett
Medico-Legal Investigations Ltd, UK

20. Effective Budgeting of Clinical
Research Studies
David W Dalton
Ixion Consulting Ltd, UK

LIST OF SUPPPLEMENTS

S1. Role of Data Management in Clinical Development
Sheila Varley

S2. Research Ethics Committees
Frank Wells

S3. Choosing a CRO: The Foundation of a Successful Partnership
Kenneth A Getz

S4. Outcome measures in the evaluation of intensive care
Nigel R Webster

S5. Surrogate end-points
Alan Bye

S6. Laboratories in Clinical Trials
Ann Speaight

S7. Performance Management in Clinical Research: Understanding and Managing Costs
Steve Arlington and Andrew Brown

S8. Benchmarking in the pharmaceutical industry
Alison Drasdo

S9. Planning multinational clinical trials
Anne Rolland

S11. New Drug Development in Oncology
Jim Cassidy

S12. Outcome Measures in Clinical Trials of Pain
G C Fenn

S13. Clinical Trials in China
Gamal Hammad and A Kamel Mashhour

S14. Clinical Trials of Medicines in Children
Imti Choonara

S15. Central and Eastern Europe – fertile ground for clinical trials
Lillian Natorff

S17. e-Clinical Trials
Andy Richardson

S18. The Challenge of Patient Recruitment
Jane Baguley

S19. Use of human microdosing studies to improve the pharmacokinetic/bioavailability (PK/BA) quality of new drug candidates
Ian Wilding

S20. Commercial input into development plans
Philip Blake

S21. Confronting the challenges in developing a biosimilar medicinal products
Cecil Nick

S22. Clinical trials in Central and Eastern Europe
Jean-Pierre Tassignon

S23. Using Patient-Reported Outcomes as tools for clinical practice: a new paradigm
Benoit Arnould

S24. Simulation of Clinical Trials
Tony Greenfield

S25. MedDRA: Medical Dictionary for Regulatory Activities
Christina Winter

S26. Paediatric Dose Ranging Studies
E David G McIntosh

S27. Nanoopharmaceuticals
Raj Bawa

S28. ‘Informed consent' in clinical research: legal background and regulations
Esther Sabel and Stephen I Ankier

"Each chapter is well written and comprehensive with useful overlap between chapters so that it is easy to see how the areas 'join up' ... a very positive addition to the library." Review in Pharmaceutical Physician

"A real manual - user-friendly, printed and edited in a style that induces the reader to continual consultation." Applied Clinical Trials

"A Good buy with chapters of interest to a wide range of people." Clinical Research Focus

"A very useful reference document." ESRA Rapporteur

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