SPECIAL NOTICE
A -- Evaluation of Model-Based BioEquivalence Statistical Approaches for Sparse Designs PK Studies
- Notice Date
- 8/2/2019
- Notice Type
- Synopsis
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- 4041 Powder Mill Road Beltsville MD 20705
- ZIP Code
- 20705
- Solicitation Number
- FDA-NOI-1216109
- Response Due
- 8/16/2019
- Point of Contact
- Yvette R. Brown, Lead Contract Specialist, Phone 2404027559
- E-Mail Address
-
Yvette.Brown@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- The Food and Drug Administration, Office of Acquisitions and Grants Services intends to solicit and negotiate, pursuant to authority of 41 United States Code (U.S.C.) 3304(a)(1), as set forth by Federal Acquisition Regulation (FAR) 6.302-1(a), with Instit National Sante Et La Recherche Medicale (INSERM), France, to develop, evaluate and compare model-based methods to analyze bioequivalence (BE) studies with sparse PK designs with the aim to find adequate statistical approaches to control type I errors and to achieve enough power to conclude BE using nonlinear mixed-effects models (NLMEs). NOTE: THIS NOTICE WAS NOT POSTED TO FEDBIZOPPS ON THE DATE INDICATED IN THE NOTICE ITSELF (02-AUG-2019); HOWEVER, IT DID APPEAR IN THE FEDBIZOPPS FTP FEED ON THIS DATE. PLEASE CONTACT 877-472-3779 or fbo.support@gsa.gov REGARDING THIS ISSUE.
- Web Link
-
Link To Document
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-NOI-1216109/listing.html)
- Record
- SN05390929-F 20190804/190802230024 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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