Intravenous Stable Isotope Glycerol for Clinical Research

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is seeking a contractor to provide intravenous stable isotope glycerol for clinical research. The contractor will be responsible for sourcing the raw material, packaging and/or manufacturing the isotope product, and submitting and releasing the product to the NIH Clinical Center Pharmacy following microbial and analytical testing. The stable isotopes will be used in human metabolic clinical studies, and the contractor must meet the minimum requirements outlined by the NIH Sterile Products for Human Administration (SPHA) Executive Committee and the NIH Office of Research Support and Compliance. Key points to consider: • The contractor must source the raw material and manufacture the isotope product. • The contractor must submit and release the product to the NIH Clinical Center Pharmacy following microbial and analytical testing. • The stable isotopes will be used in human metabolic clinical studies. • The contractor must meet the minimum requirements outlined by the NIH SPHA Executive Committee and the NIH Office of Research Support and Compliance.