Six units are tested to provide the minimal statistical significance.
thank you mr.ahmed
what my concern is why dont you get the Accuracy, Precision and Reproducibility with some other no of units might be less or more
*QUESTION*:
Why we take 6 or 12 units in Disintegration or Dissolution Study ?*
*ANSWER* :
*Mean & Standard deviation (SD)* of any in-process or finished product CQA represents *Accuracy & Precision* of any Statistically Contolled Stable Process or Method. In Disintegration & Dissolution test method, Mean & SD are the main parameters for evaluation.
& in a Control State of process/method, *99.73% of population data will be randomly normally distributed & will lie within the range of (Mean (+&-) 3*SD) i.e. Total 6 SD*
So, there will be only 0.27% probability that any observations falls outside this range.
Hence, if only *Common Cause(s) of Variation* are present within method or process, then all the data will fall within this range; if any value found outside this range then it indicates the presence of *Special Cause(s) of Variation*.
(Data of *6 units* will be assumed to lie within (Mean +/- 3 sigma = *Total 6 SD*), which will indicate Cp= 1.00 (minimum requirement in pharma industry), means it follows 3 sigma = 99.73% population data will lie within this range
While, if we consider *12 units*, then all the data will be assumed to lie within (Mean +/-6 SD = *Total 12 SD*), which will give Cp=2.00, means it follows 6 sigma = 99.999998% population data will fall within this range)
More the Sample Size, less will the Variability of the process.
Why we take 10 units to measure the UOD results, is there any reason to select 10 units
What is the meant of Q+5% in dissolution. Why we add 5% in addition to Q Value.
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