Note: This webinar was originally presented with BioPharm International.
Stability testing programs are a vital step in getting a new drug product or drug substance to market. ICH guidelines are in place to ensure drug quality isn’t compromised while stored in proper conditions and to determine the shelf life of new drugs. These guidelines also help determine proper shipping and distribution of a product and how a drug product should be administered in its final clinical setting.
This webinar will help you design an in-use stability program while overcoming the potential challenges that may hamper your program. Some of the topics to be discussed include:
- Program design: Storage conditions and time points; Storage and testing plans
- Material supply
- Testing schedule and interpreting results
Niall Dinwoodie, BSc MSc CChem MRSC
Senior Director, Global Analytical Services
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