| Document Type
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BL
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| Record Number
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652819
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| Doc. No
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dltt
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| Title & Author
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Nonclinical study contracting and monitoring : : a practical guide /\ edited by William F. Salminen, Joe M. Fowler, James Greenhaw
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| Publication Statement
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Amsterdam ;Boston :: Elsevier Science/AP,, c2013
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| Page. NO
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xi, 249 p. :: ill. ;; 23 cm
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| ISBN
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9780123978295
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: 0123978297
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| Notes
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Includes index
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| Contents
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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
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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
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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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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
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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
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Chapter 14 -- Final Report, Study Close-Out, and Conclusions
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| Abstract
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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
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Clinical Laboratory Techniques-- standards
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Contract Services-- organization administration
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Evaluation Studies as Topic
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Medical Laboratory Science-- standards
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Medical laboratories
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| NLM classification
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2013 D-210
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QY 25
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| Added Entry
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Salminen, William F
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Fowler, Joe M
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Greenhaw, James
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