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Nonclinical study contracting and monitoring : a practical guide /
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 rep...
| Clasificación: | Libro Electrónico |
|---|---|
| Otros Autores: | , , |
| Formato: | Electrónico eBook |
| Idioma: | Inglés |
| Publicado: |
Amsterdam ; Boston :
Elsevier Science,
2013.
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| Temas: | |
| Acceso en línea: | Texto completo |
MARC
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| 001 | SCIDIR_ocn823722687 | ||
| 003 | OCoLC | ||
| 005 | 20231117044821.0 | ||
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| 020 | |a 9780123978318 |q (electronic bk.) | ||
| 020 | |a 0123978319 |q (electronic bk.) | ||
| 020 | |z 9780123978295 |q (p-ISBN) | ||
| 020 | |z 0123978297 |q (p-ISBN) | ||
| 035 | |a (OCoLC)823722687 |z (OCoLC)841561355 |z (OCoLC)843068338 |z (OCoLC)852970427 |z (OCoLC)1058097821 |z (OCoLC)1065671509 | ||
| 050 | 4 | |a R860 | |
| 060 | 4 | |a QY 25 | |
| 072 | 7 | |a MED |x 108000 |2 bisacsh | |
| 082 | 0 | 4 | |a 610.28/4 |
| 245 | 0 | 0 | |a Nonclinical study contracting and monitoring : |b a practical guide / |c edited by William F. Salminen, Joe M. Fowler, James Greenhaw. |
| 260 | |a Amsterdam ; |a Boston : |b Elsevier Science, |c 2013. | ||
| 300 | |a 1 online resource (xi, 249 pages) : |b illustrations | ||
| 336 | |a text |b txt |2 rdacontent | ||
| 337 | |a computer |b c |2 rdamedia | ||
| 338 | |a online resource |b cr |2 rdacarrier | ||
| 588 | 0 | |a Print version record. | |
| 504 | |a Includes bibliographical references and index. | ||
| 505 | 0 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a 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. | |
| 505 | 8 | |a Chapter 14 -- Final Report, Study Close-Out, and Conclusions. | |
| 520 | |a 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. | ||
| 650 | 0 | |a Medical laboratories. | |
| 650 | 1 | 2 | |a Clinical Laboratory Techniques |x standards |0 (DNLM)D019411Q000592 |
| 650 | 2 | 2 | |a Contract Services |x organization & administration |0 (DNLM)D003284Q000458 |
| 650 | 2 | 2 | |a Evaluation Studies as Topic |0 (DNLM)D005069 |
| 650 | 2 | 2 | |a Laboratories |x organization & administration |0 (DNLM)D007753Q000458 |
| 650 | 2 | 2 | |a Laboratories |x standards |0 (DNLM)D007753Q000592 |
| 650 | 2 | 2 | |a Medical Laboratory Science |x standards |0 (DNLM)D013677Q000592 |
| 650 | 2 | |a Laboratories |0 (DNLM)D007753 | |
| 650 | 6 | |a M�edecine |x Laboratoires. |0 (CaQQLa)201-0007336 | |
| 650 | 7 | |a MEDICAL |x Instruments & Supplies. |2 bisacsh | |
| 650 | 7 | |a Medical laboratories |2 fast |0 (OCoLC)fst01014264 | |
| 655 | 4 | |a Internet Resources. | |
| 700 | 1 | |a Salminen, William F. | |
| 700 | 1 | |a Fowler, Joe M. | |
| 700 | 1 | |a Greenhaw, James. | |
| 776 | 0 | 8 | |i Print version: |t Nonclinical study contracting and monitoring. |d Amsterdam : Elsevier Science/AP, �2013 |z 9780123978295 |w (OCoLC)839920805 |
| 856 | 4 | 0 | |u https://sciencedirect.uam.elogim.com/science/book/9780123978295 |z Texto completo |