ICH Q1C Stability testing: requirements for new dosage forms

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Adopted guideline

Reference numberCPMP/ICH/280/95
Published01/01/1998
Published01/01/1998
KeywordsStability, dosage forms, line extension
DescriptionThis document addresses the recommendations on the data to be submitted regarding stability of new dosage forms by the owner of the original application, after the original submission for new active substances and medicinal products.


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