The Contractor shall serve as a pharmacokinetic resource in support of the pharmacokinetic (PK) and pharmacodynamic (PD) aspect of the medications development program. PK studies are carried out to determine the absorption and disposition of a drug in the body and PD studies are carried out to determine the pharmacological effects of a drug. PK and PD studies provide a means to determine the relationships among dose, plasma concentration and pharmacological effect. The PK and PD data provide a basis for the selection of promising medications for further clinical development and for the rational design of dosage regimens. Therefore, PK and PD studies are essential for the development of effective medications and are required in every phase of medication development. Pk and PD information of this sort is a requirement of the Food and Drug Administration (FDA) for the approval of new drugs. The Contractor shall prepare protocols, monitor studies to assure that pertinent FDA regulations are met, compile and edit data, conduct PK, PD and statistical analyses, and prepare reports. The data/report will be submitted to the FDA in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications).

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research and Development Contracts (N01)
Project #
N01DA068054-008
Application #
6353416
Study Section
Project Start
1996-09-23
Project End
2000-09-22
Budget Start
2000-09-07
Budget End
2001-09-30
Support Year
Fiscal Year
2000
Total Cost
$363,770
Indirect Cost
Name
Biopharmaceutical Research Consultants
Department
Type
DUNS #
City
Dexter
State
MI
Country
United States
Zip Code
48130
Ciraulo, Domenic A; Hitzemann, Robert J; Somoza, Eugene et al. (2006) Pharmacokinetics and pharmacodynamics of multiple sublingual buprenorphine tablets in dose-escalation trials. J Clin Pharmacol 46:179-92
Houtsmuller, Elisabeth J; Notes, Lisa D; Newton, Thomas et al. (2004) Transdermal selegiline and intravenous cocaine: safety and interactions. Psychopharmacology (Berl) 172:31-40