06-12-2012, 03:45 PM
Applications of Statisticsin Stability testing
Applications of Statistics.ppt (Size: 377 KB / Downloads: 51)
What is Stability?
FDA Guideline (1987)
The capacity of a drug product to remain within specifications established to ensure its identity, strength, quality, and purity.
ICH Guideline (2003)
The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light (storage conditions) and to establish a shelf life and recommended storage conditions.
Prior to expiration date, all characteristics of drug product must remain within approved specification.
Why we do need Stability?
FDA requirement
For every drug product on the market, an expiration date must be indicated on the immediate container label
Purposes
To characterize the degradation of a drug product
To establish an expiration dating period applicable to all future batches of the drug product
To ensure that the drug product will retain its identity, strength, quality, and purity through out the expiration period
Definitions
Formal stability studies
Long-term and accelerated (and intermediate) studies undertaken on primary and/or commitment batches according to a prescribed stability protocol to establish or confirm the shelf life of a drug product.
Long-term testing
Stability studies under the recommended storage conditions for the shelf life proposed (or approved) for labeling, establish or confirm the shelf life of a drug product.
Accelerating testing
Studies designed to increase the rate of chemical degradation or physical change of a drug product by using exaggerated storage conditions
How to determine shelf-life
FDA guideline (1987)
P.31
“ An acceptable approach for drug characteristics that are expected to decrease with time is to determine the time at which the 95% one-sided lower confidence limit … for mean degradation curve intersects the acceptable lower specification limit.”
P. 32
“ … , we may be 95% confident that the average drug product characteristic (e.g., strength) of the dosage units in the batch is within specifications up to the end of the expiration dating period.”