Manufacture of Bulk Chemicals and Bulk Pharmaceutical Ingredients for Preclinical and Clinical Studies

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The Developmental Therapeutics Program (DTP) at the National Cancer Institute (NCI) supports the NCI's Experimental Therapeutics (NExT) program to facilitate the transition of novel drug discoveries into clinical trials of new cancer therapeutic agents. One of essential parts of the program involves the manufacture and supply of bulk chemicals/drugs that are prepared under the current Good Manufacturing Practice (c-GMP). The bulk drugs will be used to support pre-clinical studies and to prepare clinical products that are necessary to support human clinical trials under the NCI sponsorship or investigator initiated INDs.