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

Notice Date

August 20, 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 28, 2001

Point of Contact

Gwen Hubbard, Purchasing Agent, Phone (301) 827-7172, Fax (301) 827-7103, Email ghubbard@oc.fda.gov -- Debbie Hammond, Contract Specialist, Phone (301) 827-7157, Fax (301) 827-7151, Email dhammon1@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:=20 1) ability to design pharmacokinetic and bioequivalence studies;=20 2) a basic understanding of biopharmaceutics principles as it pertains to formulation factors that can potentially alter drug absorption characteristics; =20 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.=20 The government shall base it award selection on the best combination of technical capabilities and proposed price. =20 SCOPE OF WORK: The contract expert will work with the CVM pharmacokinetics expert to provide bioequivalence reviews for CVM. The contract experts will review bioequivalence data and/or bioequivalence study protocols, as well as data provided as background information in support of the protocol development. Review responsibilities of the contract expert will include the review of the bioanalytical methods associated with the blood, urine, and/or tissue drug concentrations, including all supportive information regarding methods validation and performance characterization. The contract expert will assess the accuracy of the sponsor?s parameter estimates and will evaluate the appropriateness of the statistical model used in the final data analysis. When necessary, the expert will correct the data analysis, or will terminate the analysis if the analytical method/quantified drug concentrations are found to be invalid, if the method is improperly validated, or if there are fatal flaws in the study design. =20 When reviewing study results, the pharmacokinetics expert will use either original or corrected pharmacokinetic parameter values to evaluate the data in terms of the sponsor?s stated study hypothesis. In reviewing these submissions, the contract expert will apply knowledge of pharmacokinetic principles, animal physiology, biopharmaceutics, statistics, and bioanalytical methods validation. At times, new or revised pharmacokinetic protocols and/or methods of statistical analysis may need to be developed to address relevant problems that arise in the course of conducting these reviews and evaluations.=20 For the completed studies, the process will result in a written, comprehensive and concise evaluation of the kinetic, statistical and bioanalytical methods evaluation. The report will include any inferences drawn from supportive data. Included in this written report will be an evaluation of the study protocol and an assessment of whether or not executed studies complied with an agreed upon study design (for submitted final study reports). For completed studies, the contract expert?s written report will include an interpretation of the study results, a summary of the strengths and weakness of the study design and/or statistical analysis, performance of the analytical method, and the significance of the finding as it pertains to the stated study objective. For protocol reviews, the report will include an evaluation of any background data submitted in support of the proposed study design and an assessment of whether the proposed study design is adequate for the stated study objective. Prior to conducting these reviews, the contract expert will engage in a telephone conference with the CVM pharmacokinetics expert to ensure that appropriate points will be addressed. Upon concluding the review, the contract expert will communicate all findings to the CVM expert, both in writing and verbally. Included in the contract expert?s written evaluation will be a transmit to sponsor section, if applicable, as well as an evaluation of the clinical pharmacology section in sponsor?s proposed Freedom of Information (FOI) summary and product label insert, if applicable. Evaluation Factors will be based on best technical and proposed price. Standard Clauses: SF3398-Confidentiality , FDA 1350-Conflict of Interest, FAR 52.227-17 and 52.227-18 Copyright Clauses, FDA 1354 Physical Security (for off-site review work) Please send hand delivered proposals to Gwen Hubbard, 5630 Fishers Lane, Room 2129, Rockville, MD 20857, phone (301) 827-7172 regarding this 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

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Record

Loren Data Corp. 20010822/BSOL001.HTM (D-232 SN50V4D4)