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Matches in Library of Congress for { <http://lccn.loc.gov/2012554627> ?p ?o. }

• 2012554627 abstract "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 -- Source other than Library of Congress.".
• 2012554627 contributor B12685805.
• 2012554627 created "c2013.".
• 2012554627 date "2013".
• 2012554627 date "c2013.".
• 2012554627 dateCopyrighted "c2013.".
• 2012554627 description "Chapter 14 -- Final Report, Study Close-Out, and Conclusions.".
• 2012554627 description "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.".
• 2012554627 description "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.".
• 2012554627 description "Includes bibliographical references and index.".
• 2012554627 description "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 -- Source other than Library of Congress.".
• 2012554627 description "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.".
• 2012554627 description "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.".
• 2012554627 extent "xi, 249 p. :".
• 2012554627 identifier "0123978297 (pbk.)".
• 2012554627 identifier "9780123978295 (pbk.)".
• 2012554627 issued "2013".
• 2012554627 issued "c2013.".
• 2012554627 language "eng".
• 2012554627 publisher "London ; Waltham, MA : Elsevier Science/Academic Press,".
• 2012554627 subject "2013 D-210".
• 2012554627 subject "610.72/4 23".
• 2012554627 subject "Clinical Laboratory Techniques standards.".
• 2012554627 subject "Contract Services organization & administration.".
• 2012554627 subject "Evaluation Studies as Topic.".
• 2012554627 subject "Medical Laboratory Science standards.".
• 2012554627 subject "Medical laboratories.".
• 2012554627 subject "QY 25".
• 2012554627 subject "R860 .N66 2013".
• 2012554627 tableOfContents "Chapter 14 -- Final Report, Study Close-Out, and Conclusions.".
• 2012554627 tableOfContents "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.".
• 2012554627 tableOfContents "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.".
• 2012554627 tableOfContents "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.".
• 2012554627 tableOfContents "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.".
• 2012554627 title "Nonclinical study contracting and monitoring : a practical guide / edited by William F. Salminen, Joe M. Fowler, James Greenhaw.".
• 2012554627 type "text".