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A practical guide to writing robust chemistry, manufacturing, and controls dossier modules to support first-in-human trials
Checklist
A practical guide to writing robust chemistry, manufacturing, and controls dossier modules to support first-in-human trials.
Do you need to get your first-in-human (FIH) paperwork in order? This informative checklist can help you draft phase-appropriate chemistry, manufacturing, and controls (CMC) modules for the common technical document (CTD).