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Expiry Dating: A Complex Mathematical Puzzle

Many times, during the course of a pharmaceutical clinical study, expiration dating and the extension of clinical product beyond the original date becomes a critical need for sponsors. Dan Zuccarello at Sharp Clinical Services shows how through statistical analysis based upon both first-order kinetics and the use of the Arrhenius Equation, we can offer this rationale to clients in an effort to provide scientific reasoning that can reasonably extend the expiry of the product.

 

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