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Good research practices : a practical guide to the implementation of the GxPs

Author: N J Dent
Publisher: Oxford : Boston : Butterworth-Heinemann, 1997.
Edition/Format:   Print book : EnglishView all editions and formats
Summary:

This text has been designed as a guide to implementing good research and quality practices. This book covers practical problems of auditing multinational studies, and offers an introduction to the  Read more...

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Document Type: Book
All Authors / Contributors: N J Dent
ISBN: 0750622660 9780750622660
OCLC Number: 35657947
Description: xv, 522 pages : illustrations, maps ; 24 cm
Contents: 1. The practical quality assurance unit: observations for the 21st century / R.L. Hutchison --
2. Good manufacturing practices in the manufacture of drug products for clinical trials / E. Brown --
3. Good laboratory practice in animal health studies / B.C. Warren --
4. Good laboratory practice in animal vaccine / R.H. Visanji --
5. Good research practice --
the way forward / R. Brase --
6. Conducting clinical trials in Slovenia / B. Rozman --
7. Dealing with, and setting up, clinical trials through a contract research organization --
a guidance document / S. Ollier --
8. Preparation for an FDA inspection for clinical studies conducted under a US IND / T. Ott.
Responsibility: edited by Nigel J. Dent.

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'The book abounds with practical tips and lessons from hard-earned experience.. ..it provides fascinating insights into the parallel processes of the development of medicines for human beings and Read more...

 
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