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How Can You Manage the Complexity of Early Phase Clinical Development?

XTalks

Cohen says this new infrastructure has been unveiled at Fortrea’s Leeds location in the UK and expanded to a couple of US clinics to include new Current Good Manufacturing Practice (CGMP) pharmacies.

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Common Pitfalls in Preparing an IND Application

Advarra

Leaving Out Pertinent Chemistry, Manufacturing, and Controls (CMC) Details. Using nonclinical data or manufacturing information that doesn’t adequately support the clinical protocol hurts the IND application.