Dissolution Testing Development / Quality Control and in vivo Relevance

This GMP Education Course on Dissolution Testing aims at providing delegates with a sound understanding of the principles and best practices in dissolution testing.

As Dissolution represents a very interdisciplinary topic, a broad variety of areas within the development and commercial phase will be discussed. You will get to know

Due to the wide range of applications and the sensitivity of dissolution testing, sound method development and validation is of essential importance. Furthermore, also knowledge on dissolution apparatus qualification, dissolution specification setting, dissolution profile comparison and handling of OOS/OOE results will be trained and discussed.

The dissolution test is a key test parameter for assessing the performance of solid and semi-solid dosage forms in both drug development and quality control. In these fields it is used to assure batch-to-batch quality as well as providing process control information as part of the approach to Process Validation.

Dissolution testing is usually connected to in vivo performance because the API must be released from the formulation in the gastro intestinal tract (GIT) before in vivo absorption can occur. Therefore, dissolution testing is generally employed during Drug Product development and optimization. A dissolution test should therefore have adequate discriminatory power to detect relevant Drug Product changes.

Where dissolution testing data can be shown to be correlated to in vivo performance, clinical trials may be avoided by in vitro dissolution studies under certain circumstances, thereby reducing development time and costs.

There are many dissolution  guidance and associated guidelines (e.g. FDA, EMA and the Pharmacopoeias) dealing with Scale-up and Post-Approval Changes, Bioequivalence studies, Waiver of in vivo Bioavailability and Bioequivalence Studies. Additionally, there are some country-specific dissolution requirements which are very challenging for global pharmaceutical companies.

This GMP Education Course will, therefore, cover the following topics:

In addition, the expectations of the European Medicines Agency (EMA) and of the pharmacopoeias (Ph.Eur. 2.9.3 and USP Chapters <711> and <1092>) including USP Reference Standard Tablets and Mechanical calibration for the dissolution apparatus qualification will be discussed.

The objective of this course is to cover all aspects of dissolution testing with a focus on practical examples. Workshops are also part of the course in order to encourage the exchange of experience and to allow interactive and in depth discussions of the subject.