CHANGES IN CLEARANCE OF ANTIEPILEPTIC DRUGS DURING PUBERTY 

NIH GUIDE, Volume 25, Number 3, February 9, 1996

 

RFP AVAILABLE:  NIH-NINDS-96-05

 

P.T. 34



Keywords:

  Anticonvulsants 

  Bioassay 

  Clinical Medicine, General 

 

National Institute of Neurological Disorders and Stroke

 

The National Institute of Neurological Disorders and Stroke (NINDS),

NIH will solicit proposals for performance of an observational study

that will use a cross-sectional design to investigate the clearance

of antiepileptic drugs (phenytoin, carbamazepine, valproate, and

lamotrigine) in male and female patients during age ranges that will

include pre-, peri-, and post-pubertal stages.

 

Offerors are required to have an existing, appropriate laboratory for

assay of antiepileptic drugs in blood or plasma.  Performance of work

under this project will require an offeror to have access to a

patient population sufficient to enroll and complete a target number

of 64 patients being medically treated for epilepsy at their site.

Offerors shall have personnel on staff with established clinical

expertise in the treatment of epilepsy and experience in evaluating

and recruiting suitable patients.

 

It is anticipated that up to 10 contracts will be awarded for a

maximum period of 21 months each.  Payment will be on a

cost-reimbursement basis for the three-month preparation phase and on

a fixed price per patient basis for the eighteen-month study conduct

phase.

 

INQUIRIES

 

This is not a Request for Proposals (RFP).  RFP No. NIH-NINDS-96-05

will be issued on or about February 5, 1996.  Proposals will be due

approximately sixty days after issuance of the RFP.  All responsible

sources may submit a proposal that will be considered by the NINDS.

To receive a copy of the RFP, submit a written request and two

self-addressed mailing labels to:

 

Raina Cervantes

Contracts Management Branch

National Institute of Neurological Disorders and Stroke

Federal Building, Room 901

7550 Wisconsin Avenue, MSC 9190

Bethesda, MD  20892-9190

Reference:  RFP No. NIH-NINDS-96-05

 

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