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2023 RAPS Article of The Year: Addressing the Risks of Nitrosamine Contamination in Pharmaceuticals

Date: October 19th, 2023 at 11 am EDT. Nitrosamines in pharmaceuticals became a topic of...

In Vitro Diagnostics for Early Cancer Detection

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Recovering from an Unsatisfactory/Disastrous Pre-IND Meeting

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Strategic Considerations for Bridging

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Pillars of Success for 505(b)(2) Drug Development

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In Silico Trial Design in Development of Rare Disease Cell and Gene Therapies

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IND-Enabling Nonclinical Studies: Are You Prepared?

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The 505(b)(2) Pathway: Getting to the Clinic Faster

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Leveraging the Target Product Profile (TPP) to Maximize Breakthrough Potential

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How Commercial Insights Can be Used to Maximize an Early Exit

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