Umfang:
Online-Ressource (XII, 212p. 4 illus, digital)
Ausgabe:
1
ISBN:
9781461400493
Serie:
SpringerLink
Inhalt:
Charles B. Spainhour
Inhalt:
The last 10 years have seen a seismic shift in therapeutic product development and testing. In both the pharmaceutical (both small and large molecule) and medical device sectors, the vast majority of testing and evaluation of products is not performed within innovator companies, but rather has been outsourced to a growing universe of commercial organizations. The authors both have more than 30 years experience in this field, and both have worked within innovator companies, for CROs, and as consultants in the field. "Contract Research and Development Organizations: Their Role in Global Pro
Anmerkung:
Includes bibliographical references and index
,
Contract Research and Development Organizations; Preface; Contents; Chapter 1: Introduction; Chapter 2: Pharmaceutical Development; Chapter 3: Medical Device Development; Chapter 4: Functions and Types of CROs; Chapter 5: Selection of CRDOs; Chapter 6: CROs in China, India, and Elsewhere in the Broader World: Outsourcing Science Gone Global; Chapter 7: Contracting, Pricing, and Cost of Works Performed by CROs; Chapter 8: Monitoring Ongoing Studies and Work; Chapter 9: Common Problems and Solutions; Appendix AToxicology Labs; Appendix B Medical Device Labs; Appendix CPhase I Labs
,
Appendix DAnalytical LabsAppendix E GMP Contract Facilities; Appendix FFormulation; Appendix G Dosage Forms; Appendix HClinical Testing; Appendix IRegulatory Services; Appendix J Contract Laboratory Audit Check List; Appendix KContract Manufacturer Audit Check List; Appendix LContract Laboratory Audit Check List (GCP); About the Author; Index;
Weitere Ausg.:
ISBN 9781461400486
Weitere Ausg.:
Buchausg. u.d.T. ISBN 9781461400486
Sprache:
Englisch
Schlagwort(e):
Auftragsforschung
;
Arzneimittelentwicklung
;
Pharmazeutische Industrie
;
Outsourcing
DOI:
10.1007/978-1-4614-0049-3
URL:
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