BIOTECHNICAL TESTING FOR PSILOCYBIN, PSILOCIN AND PSILOCIN GLUCURONIDE |
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| (contract last updated 08/23/2013) | |||||||||||||||||||||||||||||||||||||||||||
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SCOPE: Contract for the purchase of bioanalytical testing for Psilocybin, Psilocin and Psilocin Glucuronide.
The scope of the proposed work for which proposals are sought is to develop and validate assays for psilocybin and its metabolites psilocin and psilocin glucuronide in plasma and urine samples obtained from 12 adult human volunteers. The study is intended to support a future NDA for psilocybin, so the quality of the work and reports must meet cGLP standards of the FDA and ICH and be acceptable to these agencies.
The clinical trial is intended to begin in the Fall of 2013, so the timeliness of assay development and validation is a consideration. Assay development and validation should be completed within 6-8 weeks of project start. Subsequent plasma and urine sample analysis can be batched, but analysis and any needed re-analysis should be completed within 2 months of the completion of sample collection. Because the same assay that is developed and validated must be used in the actual analysis of the volunteer-obtained samples, the same laboratory must be used throughout.
The number of expected plasma (576) and urine (72) samples is given in the attachment. It is not expected that this number will increase. However, the number of samples assayed could be as low as one third of the expected number (192 vs 576 plasma and 24 vs 72 urine) if subjects only choose to receive one dose of psilocybin instead of three. For this reason, the bid should be based upon per sample charge, but based upon a minimum of 192 plasma samples and 24 urine, but allowing for cGLP-based re-analyses as needed for this range of samples. The quantifiable concentration range for psilocin in plasma should be 100 – 0.5 ng/ml. Lower quantifiable limits are desirable. Little or no psilocybin is expected in plasma and urine; the concentration range for the psilocybin assay can be the same as for psilocin. |
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| CONTRACT # | DESCRIPTION | ||||||||||||||||||||||||||||||||||||||||||
| 14-5477 | BIOTECHNICAL TESTING FOR PSILOCYBIN, PSILOCIN AND PSILOCIN GLUCURONIDE | ||||||||||||||||||||||||||||||||||||||||||
| CONTRACT ORIGIN: | ADDITIONAL INFORMATION: | ||||||||||||||||||||||||||||||||||||||||||
| UW-Madison Purchasing Services 21 N Park St, Ste 6101 Madison, WI 53715-1218 |
UW-Madison users contact: Susanne Matschull (608) 262-3198 / FAX (608) 262-4467 smatschull@bussvc.wisc.edu |
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| Non-UW-Madison users contact: Vendor Representative | |||||||||||||||||||||||||||||||||||||||||||
| COOPERATIVE PURCHASING: | YES | ||||||||||||||||||||||||||||||||||||||||||
| CONTRACT TERM: | September 1, 2013 through August 31, 2014, with automatic renewal extensions to August 31, 2016, unless amended, cancelled or rebid. | ||||||||||||||||||||||||||||||||||||||||||
| Vendor(s) |
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| Commodity Code | 115-05 193-48 962-58 |
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| Federal Employee ID # (FEIN) | 54-0898188 | ||||||||||||||||||||||||||||||||||||||||||
| F.O.B. | “D” F.O.B. DESTINATION, FREIGHT PREPAID AND ALLOWED No additional charges unless additional work is requested |
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| Terms: | N/30 | ||||||||||||||||||||||||||||||||||||||||||
| Invoicing: | Invoices shall reflect contract pricing | ||||||||||||||||||||||||||||||||||||||||||
| Pricing Information: | SEE BELOW | ||||||||||||||||||||||||||||||||||||||||||
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| Revision History |
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