Drug product statistical methods

Table 2. Statistical parameters for initial hand-over of drug product assay method, based on 4 series of 2 determinations per site (adapted from Agut et al., 2011)...

Stability—accelerated, long-term (stress studies generally not performed for drug product), statistical analysis Comprehensive summary table for batch profiles Specifications—methods, tests, limits, rationale, validation... 

Each manufacturer of a packaging component sold to a drug product manufacturer should provide a description of the quality control measures used to maintain consistency in the physical and chemical characteristics of the component. These measures generally include release criteria (and test methods, if appropriate) and a description of the manufacturing procedure. If the release of the packaging component is based on statistical process control, a complete description of the process (including control criteria) and its validation should be provided. 

Clinical Simulation Studies. These protocols allow assessment of each of the characteristics of the proposed indications described in Table 4 [27] and include the basic principles articulated by the Antimicrobial I Panel (Table 2). The design is also based on reviewer experiences gained from the development of topical antibiotic and antimicrobial drug products through the NDA process. Examples of changes or recommendations include the incorporation of a positive control to validate the performance of the study, a test product vehicle arm, and proposed statistical methods of analysis to evaluate the data. Studies must be... 

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