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First-in-Human Development Strategies

Format: PDF file | Document type: Insight Guide

Crucial and cost-effective factors to consider when transforming a pre-clinical development compound into a first-in-human, early-phase drug candidate. Drug developers must consider many factors when positioning a preclinical drug candidate to succeed in first-in-human clinical trials.

This executive summary will map out the preformulation studies needed to create the best development path for a drug candidate and describe oral and injectable clinical formulation options for short- and long-term success.


Demand led supply: A novel clinical supply approach tailored to today’s trials

The nature and scope of clinical research has changed significantly over the past decade. Studies are more complex, globalized and patient-centric than ever. Yet, the processes used to package and ship study drugs to trial sites are stuck in an earlier era, depriving sponsors of clinical supply models with the flexibility, speed and efficiency their programs demand. Now, that may be about to change with the advent of demand led supply (DLS), a clinical supply model tailored to today’s trials.

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