B -- REVIEW AND ANALYZE PHARMACOKINETIC STUDY DATA FOR PRODUCT LABEL CHANGES

Notice Date

August 6, 2001

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Division of Contracts and Procurement Management, Office of Facilities, Acquisitions, and Central Svcs 5600 Fishers Lane, HFA-511, Rockville, MD, 20857

ZIP Code

20857

Solicitation Number

V08379

Response Due

August 21, 2001

Point of Contact

Gwen Hubbard, Purchasing Agent, Phone (301) 827-7172, Fax (301) 827-7103, Email ghubbard@oc.fda.gov -- Gwen Hubbard, Purchasing Agent, Phone (301) 827-7172, Fax (301) 827-7103, Email ghubbard@oc.fda.gov

Description

The Food and Drug Administration, Center for Veterinary Medicine requires a pharmacokinetics expert to provide professional services for bioequivalence reviews. The reviews will be of bioequivalence data and bioequivalence study protocols, as well as data provided as background information in support of the protocol development. The government shall base it award selection on the best combination of technical capabilities and proposed price. Contractor must posses: 1) ability to design pharmacokinetic and bioequivalence studies; 2) a basic understanding of biopharmaceutics principles as it pertains to formulation factors that can potentially alter drug absorption characteristics; 3) Knowledge of statistics as it pertains to traditional multivariate methods applied to bioequivalence and pharmacokinetic evaluations; 4) Skill in the use of microcomputers with pharmacokinetic and statistical software; 5) Knowledge regarding analytical methods, particularly chromatographic procedures, and ability to evaluate information contained within method validation. Please contact Gwen Hubbard (301) 827-7172 for information and Scope of Work. This procurement will be awarded as a simplified acquisition in accordance with FDA subpart 13.5. The following provision also applies to this acquisition: 52-232.33 Mandatory Information Electronic Funds Transfer Payment. Please provide your federal tax identification and Dun & Bradstreet number along with two copies of your quote if submitted.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/spg/HHS/FDA/DCPM/V08379/listing.html)

Record

Loren Data Corp. 20010808/BSOL012.HTM (D-218 SN50U145)