Zdrowie i gospodarka · 6.03.1996
International Conference on Harmonisation; Draft Guideline on Stability Testing for New Dosage Forms; Availability
The Food and Drug Administration (FDA) is publishing a draft guideline entitled ``Stability Testing for New Dosage Forms.'' The draft guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guideline addresses the generation of stability information for new dosage forms for submission to FDA by the owner of the original application. The draft guideline is an annex to the ICH guideline entitled ``Stability Testing of New Drug Substances and Products.''