SOLICITATION NOTICE
H -- Analysis Studies involving Idebenone and QS-10
- Notice Date
- 4/22/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Research Contracts Br., 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852
- ZIP Code
- 20852
- Solicitation Number
- Reference-Number-NCI-30043-NV
- Archive Date
- 5/13/2003
- Point of Contact
- Deborah Moore, Purchasing Agent, Phone (301) 402-4509, Fax (301) 402-4513, - Christine Virts, Contracting Officer, Phone (301) 435-3804, Fax (301) 480-0309,
- E-Mail Address
-
dm170b@nih.gov, av6q@nih.gov
- Description
- The National Institutes of Health (NIH), National Institute of Neurological Diseases and Stroke (NINDS) intends to procure sample analysis studies involving Idebenone and QS-10 from MDS Pharma Services, 621 Rose Street, Lincoln, Nebraska 68502 The NINDS is conducting a Phase l dose escalation trial of Idebenone in patients with Friedreich?s ataxia. The doses under study range from 2.5 mg/kg to 75 mg/kg. At the high end, this is several fold higher than delivered to humans previously, and an important component of this trial is determining the pharmacokinetic profile of high dose Iodebenone and its major metabolite QS-10. Under a previous NIH study, MDS Pharma Services obtained the reference material from Takeda Pharmaceuticals (the original developer of the drug), and utilizing a protocol established by Takeda, developed a validated method for Idebenone and QS-10 in human plasma according to Good Laboratory Practice methods accepted by the Food and Drug Administration. Under this new procurement, MDS Pharma Services will analyze Idebenone and QS-10 on samples from approximately 80 patients utilizing methods validated and accepted by the FDA Industry Guidance for Method Development and Validation of methods for the measurement of drugs in biological matrices. As the only organization with a validated method for Idebenone and QS-10 in human plasma, MDS Pharmaca Services is uniquely qualified to perform this study. This procurement is commercial as defined in FAR Part 2, and this acquisition is being made in accordance with the test program using simplified procedures for certain commercial items as authorized in FAR 13.5. This is not a request for competitive quotation. However, if any interested party believes it can meet the above requirement, it may submit a capability statement. This statement must demonstrate that the analysis methods proposed have been validated in accordance with FDA standards, and utilize the protocol established by the Takeda Pharmaceuticals. This information must be furnished in writing and must contain material in sufficient detail to permit the NINDS to determine if the party meets the requirement. An original and one copy of the capability statement must be received in the contracting office, by 1 PM EDT on April 28, 2003. All questions must be in writing and can be faxed to (301) 402-4513 or sent via e-mail to dm170b@nih.gov. It is the vendor?s responsibility to ensure that all questions are received by the Government via fax or e-mail. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received in response to this notice will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. NAICS 541380.
- Record
- SN00309224-W 20030424/030422213348 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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