• By James C
  • Posted Monday, June 26, 2017

Clinical Reserach Manual 2017

In 21 chapters and 500 pages this comprehensive manual provides detailed information for both beginners and experts on matters ranging from study design and pharmacokinetics though to recruitment, monitoring, registration … - and indeed all the information required to run every phase of a clinical trial from drug discovery through to regulatory requirements. 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.

This new 2017 edition of the Clinical Research Manual includes six new chapters:

·   Dosage Form Design

·   Clinical Trials Organisation

·   Product Registration in the UK and Europe

·   Clinical Trials of Medicines in Children

·   Clinical Trials of Medicines in the Elderly

·   Using Patient-Reported Outcomes as Tools for Clinical Practice

 

Reviews:

"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."
Pharmaceutical Physician

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

"All chapters are well written and some of them are really excellent. A lot of useful information can be found both by beginners and experts."
Arzneim-Forsch/ Drug Research

ISBN  978-0-9956666-1-0   Hb   £245

ISBN  978-0-9956666-2-7   Pb   £195

 

Table of Contents

 

1. Drug Discovery

Charles JR Hedgecock, Uppsala University, Sweden

2. Planning International Drug Development

Laura Brown, TOPRA, UK

3. Dosage Form Design

Rodney Horder, Abbott International

4. Pharmacokinetics

Tarlochan Singh Gill, Medway University, UK

5. Study Design

Angela Stokes, INC Research, UK

6. Recruitment of Investigators

Jacqueline Karmel and Roy Shentall, Millenium Pharmaceuticals

7. Recruitment of Patients

Jane Baguley, Cornaxis Ltd, UK

8. Statistical Methods in Clinical Trials

Richard Kay. RK Statistics, UK

9. Clinical Trials Organization

Katie Wood, Consultant, USA

10. Quality Assurance and Clinical Research

Rita Hattemer-Apostel, Verdandi AG, Switzerland

11. Good Clinical Research Practice

Nicky Dodsworth, Premier Research, UK

12. Monitoring the Safety of Medicines

Ronald D Mann, Southampton University, UK

13. Clinical Trial Supplies

Sue Miles, PCI Pharma Services, UK

14. Product Registration in the UK and Europe

Ned Kilpatrick, Greengage Regulatory, Australia

15. Clinical Research and Trial Regulations in the USA

David Jefferys, Eisai Europe

16. Clinical Research and Trial Registration in Japan

David Jefferys, Eisai Europe

17. Ethical and Legal Aspects of Clinical Research

Arundel McDougall, Camilla Hoffman and Jo-Anne Powell, Ashurst, UK

18. Clinical Trial Report Writing

Janet Gough, Documentation, Systems and Training, USA

19. Clinical Trials of Medicines in Children

Karel Allegaert and John N Van Den Anker, European Society of Pediatric Research and

European Society of Pediatric Pharmacology

20. Clinical Trials of Medicines in the Elderly

Assem el Baghdady, AlphaBeta Pharma, UK

21. Using Patient-Reported Outcomes as Tools for Clinical Practice: A New Paradigm

Benoit Arnould, Mapi, Lyon, France