Stability Testing Challenges for Pharmaceuticals and Biologics

Prague, Czech Republic (March 27-30, 2006)

The conference will tackle all the challenges that are common to small and large molecule products on the first day, such as:Stability testing for clinical trials and the EU Clinical Trials DirectiveEarly phase stability testing & screeningPackaging developmentPreparing for an EMEA inspection for your Stability ProgrammeCost efficient design and analysis of stability studies - A practical guide to Bracketing and Matrixing

It will then have two tracks on the second day addressing Pharmaceuticals or Biologics. The biologics stream will be addressing:Specialised requirements for stability testing of vaccinesBioassay data and the potency measurement of reference standardsStability following container change: Extractables and leachables

Více: http://www.efb-central.org/index.php/Main/stability_testing_for_pharma