Abstract: Applications of Accelerated Stability Assessment Program (ASAP) in Pharmaceutical Development

Applications of Accelerated Stability Assessment Program (ASAP) in Pharmaceutical Development

SOS-2015
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The presentation describes examples in utilizing the Accelerated Stability Assessment Program (ASAP) to support various areas of application within a commercial space. Using the Arrhenius principle in combination with moisture transfer modeling and statistical data analysis, the program has provided support for formulation screening to achieve the ranking order required to deliver rapid decision pertaining to the optimal formulation.

ASAP modeling has also served as a risk assessment tool during the evaluation of packaging configurations for moisture protection of drug products and API/excipient qualification as means of minimizing cycle time of traditional screening processes. The presentation will focus extensively on the role ASAP plays in supporting a root cause investigative study into the stability issues associated with a given drug product. The presentation will also discuss the application of predictive models as an accelerated means of ascertaining the impact that various exposure levels will have on the long term stability behavior of the product degradation over its shelf life.

Applications of Accelerated Stability Assessment Program (ASAP) in Pharmaceutical Development
Llurellyn Malcolm,
Pfizer, Pearl River, New York, USA