SOLICITATION NOTICE
D -- PHARSIGHT DESKTOP SOFTWARE BUNDLE
- Notice Date
- 6/26/2013
- Notice Type
- Presolicitation
- NAICS
- 511210
— Software Publishers
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- SOL-1119606-13-DH
- Archive Date
- 7/16/2013
- Point of Contact
- Debbie Hammond, Phone: (301) 827-7157
- E-Mail Address
-
deborah.hammond@fda.hhs.gov
(deborah.hammond@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration, Office of Clinical Pharmacology (OCP) in the Center for Drug Evaluation and Research is requesting an annual license renewal of the Pharsight Corporation Desktop Software Bundle they are currently utilizing. The Pharsight Corporation Desktop Software Bundle allows users to conduct PK/PD modeling, non-linear mixed effects modeling, in vivo-in vitro correlations, and trial simulation to address a variety of important clinical and nonclinical questions. We have been using and applying the outcomes of this tool for more than 10 years and it is essential to our review. We constantly receive submissions from different sponsors using this software product. This request supports the overall drug review program and of the FDA. The continued use of this software allows OCP to complete IND and NDA drug reviews. The Pharsight Corporation is the only maker of this particular software. The Pharsight Corporation Desktop Software Bundle is a comprehensive software tool for PK/PD modeling, non-linear mixed effects modeling, in vivo-in vitro correlations, and trial simulation. The Pharsight Corporation Desktop Software Bundle is a unique software tool for completing these analyses." Sponsors of IND and NDA submissions provide the FDA with PK/PD modeling, non-linear mixed effects modeling, in vivo-in vitro correlations, and trial simulation data generated by the Pharsight Corporation Desktop Software Bundle. These data must be verified by FDA drug reviewers. The verification process involves re-running sponsor analyses using the Pharsight Corporation Desktop Software Bundle. Without the Pharsight Corporation Desktop Software Bundle it would not be possible to complete review of IND and NDA submissions containing these data. The item be acquired is "Desktop Software Bundle (Phoenix WinNonLin, NLME, IVIVC, Connect, Trial Simulator) annual float license - Product Code PHXBC025 - Quantity 15 Should include: Free Onsite Phoenix Training Courses Free Phoenix public training courses seats in the US when openings are available. All questions must be submitted no later than 2:00 pm Eastern Time on June 28, 2013. All responsible sources that can provide and meet the above requirement shall submit a written quotation. Quotations must be received by July 1, 2013, 9:00 a.m. Eastern Time via email to dhammon1@oc.fda.gov. If you have any questions regarding this announcement please contact Debbie Hammond at 301-827-7157.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/SOL-1119606-13-DH/listing.html)
- Place of Performance
- Address: DHHS/FDA, 10903 New Hampshire Avenue, BLDG 51, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN03100399-W 20130628/130626235314-fd379bd9800c8275f06bf7dbd9217cd8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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