Home. Q1A - Q1F Stability
NOTE FOR GUIDANCE ON STABILITY TESTING: Relevant cross-references to other ICH guidelines have been introduced. • The text on An active pharmaceutical substance not previously contained in any drug product registered.
28 Jul 2012 ICH guidelines for stability studies of pharmaceuticals.
ICH - Technical Coordination - R. Bass ICH Harmonised Tripartite Guideline The following guideline sets out the stability testing requirement for a Registration .. A pharmaceutical product type, for example tablet, capsule, solution, cream
2 Jan 2010 REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN . Stability Testing of New Drug Substances and Products. T.
of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing
2 Jan 2010 SADC GUIDELINE FOR STABILITY TESTING. 2004. This guideline . active pharmaceutical ingredient or a shelf life for the medicinal product.
7 Feb 2002 REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN. USE This Guideline has been developed by the appropriate ICH Expert Working . bracketing and matrixing to stability studies conducted in

Annons

The photo has no tags

February 2018