Container and Closure of the Drug Product

Certain parameters may be reduced in test frequency or omitted from the stability protocol for annual batches on a case-by-case basis through a Prior Approval Supplement. A justification for such a reduction or omission should be adequately provided. 

Handbook of Pharmaceutical Manufacturing Formulations Semisolid Products 

Bancroft, T. A., Analysis and inference for incompletely specified models involving the use of preliminary test(s) of significance, Biometrics, 20(3), 427 442, 1964. 

Easterling, R.G., Discrimination intervals for percentiles in regression, J. Am. Stat. Assoc., 64, 1031-1041, 1969. 

Fairweather, W.R., Lin, T.-Y.D., and Kelly, R., Regulatory, design, and analysis aspects of complex stability studies, J. Pharm. Sci., 84, 1322-1326, 1995. 

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