عنوان
پدید آورنده
موضوع
رده
کتابخانه
محل استقرار
INTERNATIONAL STANDARD BOOK NUMBER
(Number (ISBN
0123978297
(Number (ISBN
9780123978295
NATIONAL BIBLIOGRAPHY NUMBER
Number
dltt
TITLE AND STATEMENT OF RESPONSIBILITY
Title Proper
Nonclinical study contracting and monitoring :
General Material Designation
[Book]
Other Title Information
a practical guide /
First Statement of Responsibility
edited by William F. Salminen, Joe M. Fowler, James Greenhaw
.PUBLICATION, DISTRIBUTION, ETC
Place of Publication, Distribution, etc.
Boston :
Name of Publisher, Distributor, etc.
Elsevier Science/AP,
Date of Publication, Distribution, etc.
c2013
PHYSICAL DESCRIPTION
Specific Material Designation and Extent of Item
xi, 249 p. :
Other Physical Details
ill. ;
Dimensions
23 cm
GENERAL NOTES
Text of Note
Includes index
CONTENTS NOTE
Text of Note
Front Cover; Nonclinical Study Contracting and Monitoring: A Practical Guide; Copyright; Contents; List of Contributors; Chapter 1 -- Introduction; Key Points; GLPS and Nonclinical studies ; Cros and Nonclinical studies : study directors ; examples of study issues ; conclusion ; Chapter 2 -- Good Laboratory Practices; Key Points; US FDA (21 CFR part 58) And OECD GLPS; Subpart A -- General provisions ; subpart B -- Organization and personnel ; subpart C -- Facilities ; subpart D -- Equipment ; subpart E -- Testing facilities operation ; subpart F -- Test and control articles
Text of Note
Chapter 14 -- Final Report, Study Close-Out, and Conclusions
Text of Note
Chapter 9 -- Test Article ; test and control article synthesis and sourcing ; Key points; test and control article characterization ; mixtures of test articles ; test article and mixture receipt, storage, and tracking ; additional considerations ; Chapter 10 -- Study Start Through End of In-Life; test article and formulations ; Key Points; acquring animals ; pre-study meeting ; first day of dosing, protocol deviations and amendments ; study updates, data auditing, and GLP compliance; necropsy ; Chapter 11 -- Study Communication and Data Management; Key Points; handling issues that may arisre; data management
Text of Note
Study reports and archiving, communicating study results ; study audit template ; Chapter 12 -- A Study Director's Perspective on Study Monitor-Study Director Interactions; establishing the working relationship ; Key Points; setting your expectations ; the study director's expectations of you ; pre-protocol communications ; protocol development ; the pre-study meeting ; visiting the laboratory ; study updates ; study issues and the unexpected ; reporting ; conclusions ; Chapter 13 -- Draft Report; Key Points; setting expectations ; receiving the draft report ; sending comments to the laboratory ; summary
Text of Note
Subpart G -- Protocol for and conduct of a nonclinical laboratory study subpart J -- Recrods and reports ; GLP Facility inspections ; GLP auditing checklist ; Chapter 3 -- Study Design; Key Points; General study design issues ; study design checklist ; Chapter 4 -- Animal Welfare; Key Points; The "Guide"; Regulations established by the USDA under the AWA; Potential conflicts between the animal welfare requirements, GLPS, and other study requirements ; animal welfare checklist ; Chapter 5 -- Laboratory Selection; Key Points; Contacting and preliminary screening of a new laboratory
Text of Note
Visiting and auditing a new laboratory ; Laboratory selection checklist ; Chapter 6 -- Project Proposal; Key Points; Detailed study outline ; price negotiation ; detailed study outline template ; Chapter 7 -- Contracts and Business Ethics; Confidentiality ; Key Points; Contracts ; maintaining confidentiality during the study ; business ethics ; example of a confidential disclosure agreemrnt ; Chapter 8 -- Study Protocol Preparation, Review, and Approval; Key Points; Writing the first draft ; reviewing the draft protocol ; finalizing the protocol ; changing the finalized protocol ; protocol checklist
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8
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8
SUMMARY OR ABSTRACT
Text of Note
Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinica
TOPICAL NAME USED AS SUBJECT
Medical laboratories
Clinical Laboratory Techniques-- standards
Contract Services-- organization & administration
Evaluation Studies as Topic
Medical Laboratory Science-- standards
OTHER CLASS NUMBERS
Class number
2013
D-210
Class number
QY
25
PERSONAL NAME - ALTERNATIVE RESPONSIBILITY
Fowler, Joe M
Greenhaw, James
Salminen, William F
ORIGINATING SOURCE
Date of Transaction
20130523085015.0
ELECTRONIC LOCATION AND ACCESS
Electronic name
مطالعه متن کتاب [Book]
Y
