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Securing New Drug Development by Establishing and Maintaining Phase-appropriate RSM Designation from Development to Commercial Launch
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Process development runs through the entire life cycle of new drug development and plays important roles in each stage.
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Process development runs through the entire life cycle of new drug development and plays important roles in each stage. However, as the purpose of each development stage changes, the priority of the process development also changes accordingly. For the IND stage, the main purpose of process development is to scout the most efficient way within a limited timeline to produce the API, ensuring timely toxicology study and subsequent clinical trials.
Therefore, rapid delivery of API is crucial for a timely IND submission.
In this webinar, we will discuss the importance of phase-appropriate process development and various
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