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Principles of Good Clinical Practice [Minkštas viršelis]

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  • Formatas: Paperback / softback, 272 pages, aukštis x plotis x storis: 234x156x15 mm, weight: 426 g, colour line drawings, colour tables, figures
  • Serija: Pharmacy Business Administration
  • Išleidimo metai: 03-Aug-2010
  • Leidėjas: Pharmaceutical Press
  • ISBN-10: 0853697906
  • ISBN-13: 9780853697909
Kitos knygos pagal šią temą:
Principles of Good Clinical PracticeDidesnis paveikslėlis
  • Formatas: Paperback / softback, 272 pages, aukštis x plotis x storis: 234x156x15 mm, weight: 426 g, colour line drawings, colour tables, figures
  • Serija: Pharmacy Business Administration
  • Išleidimo metai: 03-Aug-2010
  • Leidėjas: Pharmaceutical Press
  • ISBN-10: 0853697906
  • ISBN-13: 9780853697909
Kitos knygos pagal šią temą:
Pastovi nuoroda: https://www.kriso.lt/db/9780853697909.html
Raktažodžiai:
Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights. Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes: informed consent; investigator and sponsor responsibilities; site monitoring; institutional review boards and independent ethics committees; clinical trial registration and reporting; quality assurance; future implications for good clinical practices. This text aims to be a one-stop source for guidance and checking the rules for proper conduct of clinical trials, as well as providing a historical perspective of the clinical research landscape. Principles of Good Clinical Practice will be a definitive text for Clinical Development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries.

Recenzijos

Selected for "The First Clinical Research Bookshelf" - Essential reading for clinical research professionals. " a readable introductory summary of Good Clinical Practice (GCP) for pharmaceutical studies based on U.S. regulations and ICH E6 guidelines, which FDA has adopted as guidance...the book strikes a good balance between too much and too little detail" Norman M. Goldfarb, Journal of Clinical Research Best Practices Vol. 7(7), July 2011 -- Norman M. Goldfarb * Journal of Clinical Research Best Practices * "...details requirements and discusses ethics surrounding clinical investigational trials. This is a worthy topic and relevant to pharmacy practice...an appropriate book for someone new to research, interested in doing research, or in an academic environment." Barbara Lane Giacomelli, PharmD, MBA, BS, FASHP (Shore Memorial Hospital) Doody's Notes, November 2010 -- Barbara Lane Giacomelli * Doody's Notes *

Preface ix
About the editors x
Contributors xii
Abbreviations xiv
1 Introduction to Good Clinical Practice
1(14)
Sean W. Develin
2 Regulatory requirements
15(26)
Catherine Burgess
Marie-Laure Papi
Kristel Van de Voorde
Guy Nys
Introduction
15(1)
International Conference on Harmonisation requirements
15(2)
The United States (US) regulatory framework
17(10)
The European Union regulatory framework
27(10)
Summary
37(4)
3 Informed consent
41(22)
Steven P. Steinbrueck
Barbara S. Davis
Elizabeth E. Bodi
Background
42(2)
Regulations and guidelines
44(1)
Introduction to form and process
44(7)
Liability, understanding, therapeutic misconception
51(3)
Developing a `gold standard'
54(3)
Leadership
57(1)
Additional topics
57(3)
Summary
60(3)
4 Investigator responsibilities
63(14)
Jesse Goldman
Michael J. McGraw
Adam N. George
Qualifications
64(1)
Assessment of the research
65(2)
Communication with the Institutional Review Board or Independent Ethics Committee
67(1)
Communication with sponsor
68(1)
Protecting safety, rights, and welfare of subjects
68(3)
Investigational product
71(2)
Safety reporting
73(1)
Assessment of causality
73(1)
Documentation and record retention
74(1)
Financial disclosure
75(1)
Inspections by health authorities
75(1)
Summary
75(2)
5 Sponsor responsibilities
77(14)
Donna W. Dorozinsky
Quality
77(1)
Medical expertise
78(1)
Study design
79(1)
Data management
80(1)
Record keeping
81(2)
Safety reporting
83(3)
Investigator selection
86(1)
Investigational product
86(2)
Registration of clinical trials
88(1)
Reporting of clinical trial results
88(1)
Summary
89(2)
6 Clinical trial design
91(18)
Steven Gelone
Patrick Scoble
Introduction
91(1)
What is clinical research?
91(1)
Historical perspective on clinical research
92(1)
Why is clinical research needed?
92(1)
The phases of drug development
93(2)
Where does clinical research begin?
95(1)
Critical concepts in clinical research
95(1)
Approaches to the design of clinical research studies
95(3)
Bias in clinical research
98(2)
Type I error, Type II error, and sample size
100(2)
Equlvalency/non-inferiority versus superiority in clinical trials
102(2)
Clinical equipoise in controlled clinical trials
104(1)
Comparison of placebo versus the best-available control group in controlled clinical studies
105(1)
Challenges in conducting clinical research
105(1)
The interpretation and Integration of clinical research into clinical practice
106(3)
7 Site monitoring
109(12)
Vickie T. Payne
Selection and qualifications of the monitor
109(1)
The evaluation visit
110(2)
The initiation visit
112(2)
The monitoring visit
114(3)
The close-out visit
117(2)
Summary
119(2)
8 Institutional Review Boards and Independent Ethics Committees
121(28)
Michael R. Jacobs
Composition, procedures, and function
122(3)
Protection of human subjects
125(3)
Review of the protocol, Investigator's Brochure, and informed consent
128(10)
Qualifications of the investigator and investigative team
138(1)
Risk-benefit analysis
139(5)
Continuing review
144(1)
Final thoughts
145(4)
9 Pharmacovigilance
149(18)
Stephen Klincewicz
Yuung Yuung Yap
Adrian Thomas
Introduction
149(1)
Adverse events
150(3)
Reporting guidelines and timeline
153(6)
Signal detection
159(2)
Databases
161(2)
Conclusion
163(4)
10 Clinical trial registration and reporting
167(16)
Barbara Godlew
Shawn Pelletier
Maureen Strange
Introduction and history
167(3)
Clinical trial registration
170(5)
Clinical trial results databases
175(2)
Legislation and regulatory requirements
177(1)
Clinical trial disclosure implications for future therapeutic development
178(2)
Summary
180(3)
11 Quality assurance
183(20)
Peter Smith
Introduction
183(1)
Defining quality
184(1)
Auditing: purpose of auditing
185(1)
The audit plan
186(2)
Conduct of the audit
188(1)
Types of audit
188(12)
Summary
200(3)
12 Future implications of Good Clinical Practice
203(12)
Thomas Jacobsen
Globalization of clinical research
203(2)
Genomics
205(2)
Gene transfer
207(1)
Stem cell research
208(2)
Nanotechnology
210(2)
Conclusion
212(3)
Appendix 1 The Nuremberg Code 215(2)
Appendix 2 World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects 217(6)
Appendix 3 The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research 223(12)
Glossary 235(10)
Index 245