REQUEST FOR STORAGE AND STABILITY STUDY OF DRUG SUBSTANCES AND PRODUCTS

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The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Division of Population Health Research (DiPHR) aims to be a leader in population health research by focusing on successful reproduction, the health and well-being of pregnant women and their infants, and the optimal growth and development of children and adolescents across the lifespan. With the population as its observational laboratory, the division uses collaboration, discovery, ethics, innovation, interdisciplinary teamwork, and mentoring as core values in fulfilling its mission and vision. NICHD needs a contractor to hold Government owned vials of clinical grade Acyline, bulk clinical grade Acyline and Metastin and bulk research grade Acyline. They will be under stability testing protocol for these vials and bulk substance to support planned and ongoing clinical trials. There is an ongoing need for stability test of the clinical grade vialed and bulk Acyline and Metastin. This is to ensure that the drug substance or product is stable when it goes into clinical trial. These drug products must be stored at -20C, and contracting and shipping them to another vendor is not cost effective. Failure to maintain these drug products would delay ongoing clinical trials and add significant cost to the Government.