SOURCE: Xtalks

Xtalks Webinars

March 03, 2015 10:05 ET

Accelerated Stability Assessment Program (ASAP) to Improve Product Development, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - March 03, 2015) - During this webinar Dr. Piero De Filippis, Stability Manager, Pharmaceutical & Preclinical Development at the Aptuit Center for Drug Discovery & Development, Verona (Italy), will discuss the use of Accelerated Stability Assessment Program (ASAP) to shorten & strengthen the drug product development process. The live broadcast takes place on Thursday, March 19, 2015 at 11am EDT (3pm GMT).

The Accelerated Stability Assessment Program (ASAP) is a new approach to stability testing, intended to accurately quantify the sensitivity of a drug substance or a drug product in a very short time to both temperature and moisture. The ASAP approach is performed by very short-term exposure of the candidate drug substance or a solid drug product (e.g. up to 2 weeks) to a range of high temperatures and humidity within a DoE-like study design, and testing samples for assay and degradation products. The results are then fitted into the ASAP equation, linking degradation to moisture and temperature. Once data are modelled, it is possible to predict the stability of the drug substance or drug product at any time, temperature and relative humidity.

This webinar will focus on showing how the ASAP approach can very well fit into different stages of a product development, shortening product development time and strengthening relevant key decisions.

For example:

  • Helping early candidate selection of moisture sensitive drug substance versions (to select the more stable and less moisture-sensitive version)
  • Not only ranking developed formulations in order of stability, as traditional single stability condition approaches, but also accurately predicting the stability of the product at fixed expiry times
  • Rapidly supporting pack selection on the basis of formulation moisture sensitivity

In addition ASAP data can also support preliminary clinical shelf-life setting in early development phases.

To learn more about this event visit: Accelerated Stability Assessment Program (ASAP) to Improve Product Development

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