Good Research Practices: A Practical Guide to the Implementation of the GXPs - Rilegato

Rilegato

ISBN 10: 0750622660 ISBN 13: 9780750622660

Casa editrice: CRC Press, 1996

Riassunto

This book has been designed as a practical guide to implementing good research and quality practices.



The need for audits and quality assurance is increasing as industry is having to validate its results to an even greater extent. The term GxP has now been coined for many of these good practices. In addition to the main ones mentioned, GMP, GLP and GCP, we are seeing an evolution of similar guidelines throughout the industry.



* covers practical problems of auditing multinational studies



* good introduction to the regulatory agencies and review of the World Health Organisation



* overall review of computers and the validation of the computer database to comply with GLP and GCP specifically



* the expert authors have been chosen for their specific in-dept knowledge of the subject about which they have written.



This practical guide will prove invaluable for scientists, regulators and research workers in quality management and quality assurance.

Su questo libro

Recensione

'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 animals.. I would have benefited from reading this book early in the course of my career
Lancet, April 1997.

Contenuti

Good laboratory practice
Preparation for good clinical practice - the investigator viewpoint
Clinical trials and good clinical practice
Multinational studies - pitfalls and benefits
Animal health industries and good clinical practice
Biotechnology
Laboratories - implementation of GxPs
Regulatory agencies and GxPs
Reporting research and development findings and statistics
Computers.

Dettagli dell'edizione

• Editore: CRC Press
• Data di pubblicazione: 1996
• Lingua: Inglese
• ISBN 10: 0750622660
• ISBN 13: 9780750622660
• Rilegatura: Copertina rigida
• Numero edizione: 1
• Numero di pagine: 522
• Redattore: Dent Nigel J.
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile