Drug Development and Industrial Pharmacy · 1981 · 11 citations · 5 references
PharmacyPharmaceutical AnalysisPharmaceuticsLyophilizationExpiration DatingPharmaceutical StabilityShelf-life AnalysisStabilityStability Of Pharmaceutical FormulationsStorage StabilityAccelerated Storage TestingDevice Expiration DateDrug Product Shelf LifeDrug Product StabilityExpiration Date DeterminationExpiration Date TrackingPharmaceutical Product RegistrationStability Study Design
The establishment of the expiration date of pharmaceutical product through the statistical treatment of stability data is discussed in detail for both the stability studies under normal storage conditions and accelerated storage conditions.
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Darragh Murnane, Graham Martin, C. Marriott · Journal of Pharmacy and Pharmacology · 2006 · 145 citations · Full text