ICH Q11
Definisjon av startmaterialer Fleksibilitet og dokumentasjonskrav Andreas Sundgren LMI 17 april 2012 Definition of Starting Materials Nonscientific approach Justification
process designspace startingdesignprocessstartingspacedocumentationamprequirementsmanufacturingmaterialsdefinitionmaterialcriticalqualityparametersreaction
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