PHARMACOKINETIC ANALYSIS RESOURCE CENTER

承包商应作为药代动力学资源支持

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).