Dr Gerd Michael Maier, Boehringer Ingelheim
In the pharmaceutical industry, drug dissolution testing is routinely used as a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. A dissolution test measures the amount of drug that goes into solution over a period of time under standardized conditions. It is used to assure batch-to-batch quality, to provide process control, and to substitute in vivo studies under certain circumstances.
This webinar targets executives and staff in development and quality control in the pharmaceutical industry. The webinar is also intended for participants from quality assurance, regulatory affairs as well as contract laboratories.
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This webinar aims at providing delegates with a sound understanding of the principles and practices in dissolution testing.
The following topics will be covered:
- Dissolution technique
- Factors affecting dissolution
- Regulatory requirements (general guidelines, USP, EP)
- Dissolution methods and apparatus
- Dissolution automation
- Qualification of dissolution apparatuses
- Development of dissolution methods