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What is ‘chemistry, manufacturing & controls’ and why is it important in drug development?

Chemistry, manufacturing and controls refers to a set of data containing detailed information on the chemical structure of the investigational compound, the stability of the compound, how it was produced and the quality controls used in manufacturing. This data must be submitted to regulatory agencies before it can be used in humans. To learn more about chemistry, manufacturing & controls and why they are important for drug development, click on the links below.

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• Therapies for Rare and Neglected Diseases, NIH: About the TRND Program
• Therapies for Rare and Neglected Diseases, NIH: Apply to TRND
• Molecular Libraries Program: NIH Chemical Genomics Center