AJ11--Pharmacokinetic Studiesview on SAM.gov

Page 2 of 2 James A. Haley VA Medical Center, 13000 Bruce B. Downs Blvd., Tampa, Florida 33612, intends to solicit emergency sole source to Charles River Laboratories for CRO services for pharmacokinetics and toxicity studies of NPC86. Charles River Laboratories will perform a pharmacokinetic study and develop a High Performance Liquid Chromatography Mass Spectrometry/Mass Spectrometry (HPLC-MS/MS) method for quantifying the labs in house-drug NPC86. Each respondent must have an established business, with an office and full time staff to include a "fully qualified" field service engineer (FSE) and a "fully qualified" FSE who will serve as backup. "Fully qualified" is based upon training and on experience in the field on VIIA7 instruments. The contractor shall provide written assurance to the competency of their personnel and a list of credentials of approved FSEs for VIIA7 specifically must demonstrate 3 years experience on each instrument. The Contracting Officer (CO) may authenticate the training requirements, request training certificates or credentials from the contractor at any time for any personnel who are servicing or installing any VA equipment. SERVICES TO BE PROVIDED: 1. Development of an HPLC - MS/MS Method for the Quantification of NPC86 in Mouse Plasma: Method Development and pre-validation testing will be conducted over 7 days. Archival of data is included for a period of 1 year(s). Matrix ordered in method development will be used as blank (control) matrix and will also be used in method validation. 2. Optimization and Qualification of an LC-MS/MS RGA2 Method for the Quantification of NPC86 in Mouse Tissues: a. An LC-MS/MS Research Grade 2 (RGA2) method will be optimized to determine appropriate conditions for the quantification of test article in mouse tissues. Method optimization will include infusion of test article to determine appropriate mass spectral settings, development of LC conditions that produce acceptable chromatography, and assessment of whether instrument sensitivity (based on matrix-free test injections) is suitable for the target assay range. b. Method optimization will be conducted by the laboratory for up to 1 day. c. A stable labeled internal standard is preferred for LC-MS/MS methods and if not supplied, the laboratory will assess a provided analog and/or generic compound for this purpose. d. A RGA2 method is intended to run a standard curve and quality control samples in tissue homogenate and can be used to support non-regulated studies. e. A previously optimized LC-MS/MS method will be qualified to support non-clinical, non-GLP studies. Method qualification will include a single run containing 2 standard curves prepared in tissue or appropriate surrogate matrix and at least 5 replicate QCs at Low,Mid, and High levels prepared in Mouse tissue homogenate. Pricing includes QCs prepared in one tissue type. May include up to1 additional tissue type at one level. Additional QCs by tissue type may be added at addi…