Jobst Limberg

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Contributors Jean-Marc Aiache, Nobuo Aoyagi, Dennis Bashaw, Cynthia Brown, William Brown, Diane Burgess, John Crison, Patrick DeLuca, Ruzica Djerki, Jennifer Dressman, Thomas Foster, Kirsti Gjellan, Vivian Gray, Ajaz Hussain, Tom Ingallinera, James Klancke, Johannes Kraemer, Henning Kristensen, Kofi Kumi, Christian Leuner, Jobst Limberg, Petra Loos, Lenny(More)
An overview is provided regarding the different use of in vitro dissolution and particular related regulatory aspects. The overview attempts to clarify the regulatory requirements in all contexts in which in vitro dissolution data are employed. The different areas comprise the development of new and generic products as well as bioequivalence between(More)
The discriminatory power of the new and the old requirements are compared on a mathematical basis and by the simulation of data. The probability of passing the requirements of the test for uniformity of dosage units versus the tests for uniformity of content and uniformity of mass are compared by the simulation of different batches. These batches are(More)
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