Review of Radiopharmaceutical IND’s and NDA’s
This is a discussion of the new drug approval process with emphasis on the chemistry, manufacturing and controls portions of investigational new drug (IND) applications and new drug applications (NDA). Most of that is applicable to radiopharmaceutical drugs as well as to non-radioactive drugs. There are some points that are unique to radioactive products, for example, radionuclidic and radiochemical identity and purity and specific activity. This will be little more than a cursory overview of that process.
KeywordsDrug Product Drug Substance Radionuclidic Purity Biological Distribution Drug Approval Process
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