The Australian Regulatory Guidelines for Prescription Medicines (ARGPM), guidance on "Stability testing for prescription medicines", recommends to predict the shelf life of chemically derived medicines from stability data by taking the worst case situation at batch release into account. Consequently, if a change over time is observed, a release limit needs to be specified. Finding a release limit and the associated shelf life is supported, as well as the standard approach that is recommended by guidance Q1E "Evaluation of stability data" from the International Council for Harmonisation (ICH).
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