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Clinical Research Manual
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Description: |
A practical, annually 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.
Review in Pharmaceutical Physician "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."
With over 600 pages and 20 chapters, Clinical Research Manual covers the entire drug development programme from Drug Discovery through to Postmarketing Surveillance
As many aspects of clinical research are constantly changing, the Manual will be updated at 12-monthly intervals. When chapters are updated subscribers will receive replacement pages to put in their binders. Each subscriber will get one update and two supplements free of charge. |
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Contents: |
CHAPTERS AND AUTHORS
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 |
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