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mAb Biosimilars 2012
Seminar
- Non-clinical studies for mAb - a risk-based approach- Clinical trials - clinical endpoints- Immunogenicity assessment- Analytical comparison and quality changes- Preclinical and clinical comparability exercises- Markus Ambrosius- Dr. Steffen Gross- Dr. Bernd Liedert- Dr. Christian Schneider- Prof. Beatriz Silva Lima
Veranstaltungs-Beschreibung
The new guideline on similar biological medicinal products containing monoclonal antibodies is expected to be finalised by the end of 2011.
We would like to give you a thorough update on the new challenges and opportunities arising in connection with this guideline, and to discuss with you the preclinical and clinical topics, as well as the quality requirements. Especially the challenging topic of comparability exercises will be addressed in detail.
May we invite you to a firsthand update?
Es sind aktuell keine Termine verfügbar
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