WA4TKSampleAnalysis.pdf
PDF 18 KB Posted
- Attached to
- Preclinical Pharmacokinetic and Pharmacological Studies of Anticancer and Other Therapeutic Agents
- Solicitation number
- N01-CM-07014-39
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WA 4 TK Sample Analysis
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RFP/N01-CM-07014-39
Attachment 22, WA 4
NCI CONTRACT WORK ASSIGNMENT
Contractor: To be filled in WA Title: Assay Implementation and Plasma Sample Analysis in support of
Toxicokinetic Studies with a Small Molecule Drug Candidate Contract No: N01-CM-________ WA No: 4 Modification No: 0 WA Originator: Project Officer Contracted WA Area:
Date Prepared: ________________
Part I. INITIATOR'S REQUEST
A. Period of Performance: Month 8 thru Month 12 (5 months total)
B. WA Description:
Assume the compound is a small molecule (MW <450) in NCI anticancer pipeline.
An LC-MS/MS method for the compound in mouse plasma has been developed previously in your laboratory. Range-finding and IND-directed toxicology studies with full PK will be carried out by another NCI contractor. In support of this effort, the following activities should be carried:
• Adapt the analytical method for determination of the compound in rat and dog plasma.
• Analyze 400 rat and 400 dog plasma samples using the above assay. The anticipated delivery schedule for these samples is as follows:
Month 1 200 rat plasma samples Month 2 200 dog plasma samples Month 4 200 additional rat plasma samples Month 5 200 additional dog plasma samples
Note the intermittent nature of the sample delivery schedule. Assume these analyses will be conducted in non-GLP mode.
• Perform standard non-compartmental pharmacokinetic analysis on the data sets generated by the above analyses.
• Prepare separate PK analysis “mini-reports” for each of the samples sets listed above. Each stand-alone report should be suitable for inclusion in the toxicology contractor’s study report.
As indicated in Part II of this form, please provide an estimate of the cost and effort required for this work assignment, as well as a description of your approach to the studies to be performed.
C. WA Leader: Fill in PI name
D. Deliverables:
(1) Interim data
RFP/N01-CM-07014-39
Attachment 22, WA 4
(1) Monthly status reports
(2) Final WA report
E. Work Assignment Response Due Date: with proposal
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