|
|
|
|
| LEADER |
00000nam a2200000z 4500 |
| 001 |
d64ecd3b-2491-46ca-aada-8a8c513e7dd9 |
| 005 |
20240707000000.0 |
| 008 |
121129s2013 ne a b 001 0 eng |
| 020 |
|
|
|a 0123978297
|
| 020 |
|
|
|a 9780123978295
|
| 035 |
|
|
|a (OCoLC)839920805
|
| 040 |
|
|
|a NLM
|b eng
|c NLM
|d KSW
|d YDXCP
|d BTCTA
|d MnU-B
|
| 042 |
|
|
|a pcc
|
| 049 |
|
|
|a BIOM
|
| 050 |
|
4 |
|a R860
|
| 060 |
0 |
0 |
|a 2013 D-210
|
| 060 |
1 |
0 |
|a QY 25
|
| 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/AP,
|c ©2013.
|
| 300 |
|
|
|a xi, 249 pages :
|b illustrations ;
|c 23 cm
|
| 336 |
|
|
|a text
|b txt
|2 rdacontent
|
| 337 |
|
|
|a unmediated
|b n
|2 rdamedia
|
| 338 |
|
|
|a volume
|b nc
|2 rdacarrier
|
| 504 |
|
|
|a Includes bibliographical references and index.
|
| 505 |
0 |
|
|a 1. Introduction. GLPs and nonclinical studies -- CROs and nonclinical studies -- Study directors -- Examples of study issues -- 2. Good laboratory practices. 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 -- Subpart G - protocol for and conduct of a nonclinical laboratory study -- Subpart J - records and reports -- CLP facility inspections -- GLP auditing checklist -- 3. Study design. General study design issues -- Study design checklist -- 4. Animal welfare -- 5. Laboratory selection. contacting and preliminary screening of a new laboratory -- Visiting and auditing a new laboratory -- Laboratory selection checklist -- 6. Projected proposal. Detailed study outline -- Price negotiation -- Detailed study outline template -- 7. Contracts and business ethics. Confidentiality -- Contracts -- Maintaining confidentiality during the study -- Business ethics -- Example of a confidential disclosure agreement --
|
| 505 |
0 |
|
|a 8. Study protocol preparation, review, and approval. Writing the first draft -- Reviewing the draft protocol -- Finalizing the protocol -- Changing the finalized protocol -- Protocol checklist -- 9. Test article. Test and control article synthesis and sourcing -- Test and control article characterization -- Mixtures of test articles -- Test article and mixture reciept, storage, and tracking -- Additional considerations -- 10. Study start through end of in-life. Test article and formulations -- Acquiring animals -- Pre-study meeting -- first day of dosing -- Protocol deviations and amendments -- Study updates, data auditing, and GLP compliance -- Necropsy -- 11. Study communication and data management. Handling issues that may arise -- Data management -- Study reports and archiving -- Communicating study results -- Study audit template -- 12. A study director's perspective on study monitor-study director interactions. Establishing the working relationship -- 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 -- 13. Draft report. Setting expectations -- Receiving the draft report -- Sending comments to the laboratory -- Summary -- 14. Final report, study close-out, and conclusions. Finalizing the report -- Amending the final report -- Study close-out -- Conclusions.
|
| 650 |
|
0 |
|a Medical laboratories
|
| 650 |
|
2 |
|a Clinical Laboratory Techniques
|x standards
|
| 650 |
|
2 |
|a Contract Services
|x organization & administration
|
| 650 |
|
2 |
|a Evaluation Studies as Topic
|
| 650 |
|
2 |
|a Medical Laboratory Science
|x standards
|
| 700 |
1 |
|
|a Salminen, William F.
|
| 700 |
1 |
|
|a Fowler, Joe M.
|
| 700 |
1 |
|
|a Greenhaw, James
|
| 999 |
1 |
0 |
|i d64ecd3b-2491-46ca-aada-8a8c513e7dd9
|l 9926555910001701
|s US-MNU
|m nonclinical_study_contracting_and_monitoringpractical_guide________________2013_______elseva___________________________________________________________________________p
|
| 999 |
1 |
1 |
|l 9926555910001701
|s ISIL:US-MNU
|i University of Minnesota
|t BKS
|a TBIOMGENS
|c QY25 N812 2013
|d NLM
|b 31951D036671086
|x BOOK
|y 23366147430001701
|p LOANABLE
|