Developmental stability testing

DRUG SUBSTANCE A. Developmental Stability Testing Batch Selection... 

Description of the container/closure system—K brief description of the primary and minimally functional secondary materials used in the packaging of the finished developmental API should be provided (e.g., double high-density polyethylene liner inside a fiberboard container/closure). Consideration should also be given to including appropriate acceptance criteria for the primary (i.e., product contact) material. The container/closure described in this section should be consistent with that used for stability testing of the compound, or exceptions should be noted. 

Depending on stability knowledge of the product, this condition may not be actively tested if the product was found to be stable at 30°C/75%RH during developmental stability studies. 

The stability of the coated sorbent alone may be a factor and must be tested. After all the developmental work is completed, the specialized sorbent is frequently useful for only one substance. 

Preliminary Testing Data Any data generated during the developmental and clinical trial phases of the drug may be useful to determine the expected manufacturing process variability. The process variability is an important factor to define the sampling plan to be used in the stability study. 

Standardization data were collected on 500 children aged 6-11 years, along with measures of general intelligence, educational attainment and classroom behaviour. Immediate, short-term and long-term (3-month or 6-month) test-retest data were obtained on subsamples. The battery is also being used with 78 children whose blood lead levels have recently been assayed. This paper describes the tests, the developmental trends they reveal and their test-retest stability. 

Because of problems with equipment, standardization testing was delayed so that it is not yet possible to report how the tests interrelate - i.e. whether there is an identifiable factor of attention and how it relates to general intelligence and teachers ratings. What can be commented on are the developmental trends and the test-retest stability of the measures. 

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