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Dissolution Testing
13-15 October 2010
Berlin, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Objectives
This GMP Education Course on Dissolution Testing aims at providing delegates with a sound understanding of the principles and practices in dissolution testing, which has become increasingly important in pharmaceutical industry.
Background
Dissolution tests are a key tool in drug development and in quality control. In these fields they are used to assess batch-to-batch quality and to provide process control – mainly for solid dosage forms.
The FDA has issued several guidances on this topic dealing with
approaches for setting specifications
the relation to the biopharmaceutical characteristics of the drug substance
dissolution methodology, apparatus, and operating conditions,
validation of the dissolution methodology and
statistical methods for comparing dissolution profiles.
These items will be covered in this course. In addition, the questions and expectations of the European Medicines Agency (EMEA) and of the pharmacopoeias (Ph.Eur. 2.9.3 and USP General Chapters <711> and <1092> including USP Reference Standard Tablets for the Performance Verification Test) will be discussed.
The objective of this course is to cover all aspects of dissolution testing with a focus on practical examples. Workshops are an essential part of the course in order to encourage the exchange of experience and to allow interactive and in depth discussions of the subject. |
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