| Description |
1 online resource (xi, 249 pages) : illustrations |
| Contents |
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 STUDYSUBPART J -- RECORDS 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 LABORATORYLABORATORY 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 AGREEMENT; 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 ArticleTEST 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; ACQUIRING 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 ARISE; DATA MANAGEMENT |
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STUDY REPORTS AND ARCHIVINGCOMMUNICATING 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 |
| Summary |
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 |
| Bibliography |
Includes bibliographical references and index |
| Notes |
Print version record |
| Subject |
Medical laboratories.
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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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Laboratories -- organization & administration
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Laboratories -- standards
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Medical Laboratory Science -- standards
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Laboratories
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MEDICAL -- Instruments & Supplies.
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Medical laboratories
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| Form |
Electronic book
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| Author |
Salminen, William F
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Fowler, Joe M
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Greenhaw, James
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| LC no. |
2012554627 |
| ISBN |
9780123978318 |
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0123978319 |
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