Statistical process control basic principles

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... 

In the developmental process for many drugs, the drug product is administered under controlled conditions to healthy, normal individuals or to the targeted patient population. This is done to characterize the rate and extent of absorption, the bioavailability, of the active drug contained in the product. The bioavailability is estimated from the measured concentrations of the drug that appear in serial blood specimens collected over a period of time after product administration. Basic statistical principles govern the behavior of the typical bioanalytical procedure used to measure these concentrations in the collected blood specimens. 

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