Which statistical methodology for drug shelf life estimation is often dictated by the "worst-case" batch in a stability study?

Answer

Fixed-batch model.

Pharmaceutical stability science employs different statistical approaches to project product endurance, which consequently affects the resulting expiration date determination. The fixed-batch model, often associated with earlier International Council for Harmonisation (ICH) guidelines, utilizes data derived from the batches tested in the formal study in a direct manner. A significant characteristic of this methodology is that the resulting estimate for shelf life is frequently determined by the performance of the single batch that exhibited the poorest stability characteristics, known as the 'worst-case' batch. This focus on the weakest link in the tested sample set contrasts with methods aiming to make broader inferences about the entire ongoing production process.

Which statistical methodology for drug shelf life estimation is often dictated by the "worst-case" batch in a stability study?

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DefinitionSafetyFDAshelf liferegulation