Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) – Critical DARS Laboratory Supplies

Posted Date: Sep 08, 2025

Due Date: Sep 12, 2025

Awarded Date: No Awarded Date

SetAside Type
No Set aside used
Solicitation ID	Solicitation Title	Solicitation Office
FDA-CDER-25-130555	Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) – Critical DARS Laboratory Supplies
Synopsis
The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is conducting a research project to examine the effect of female sex hormones on in vitro drug metabolism and transport. As part of this process, DARS needs to acquire cryopreserved human hepatocytes from multiple female donors of different age groups to conduct this research. For successful metabolism and transporter function to occur the following quality characteristics are essential for the study: Single female donor lots Three donors aged 20-35 years and three donors aged 50-70 years A minimum of 5 × 106 (5 million) viable hepatocytes .... Read More
Office Location	Agency Name	Solicitation Base Posting Type
	FOOD AND DRUG ADMINISTRATION	Combined Synopsis/Solicitation