expirest: Expiry Estimation Procedures
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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