Transcription of ICH Q5C Stability testing of Biotechnological / …
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ICH Q5C Stability testing of Biotechnological / …
An agency of the European UnionICH Q5 CStability testing of Biotechnological / biological productsICGH CGC ASEAN training. Kuala Lumpur. 30-31 May 2011 Presented by: A. Ganan Jimenez, B. Brake European Medicines Agency, Human Medicines Development and EvaluationICH Q5C - Stability testing of Biotechnological / biological products1 ContentICH Q5C Introduction Scope Selection of Batches Stability indicating profile Storage conditions testing frequency Specifications LabellingEMA guidance on StabilityICH Q5C - Stability testing of Biotechnological / biological products2 ICH Q5C Introduction Scope Selection of Batches Stability indicating profile Storage conditions testing frequency Specifications LabellingEMA guidance on StabilityICH Q5C - Stability testing of Biotechnological / biological products3 ICH Stability guidelines3 ICH website.
5 ICH Q5C - Stability testing of Biotechnological / Biological products ICH guidelines on stability (II) • Q1D –Bracketing and matrixing designs for Stability testing for new drugs substance ...
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