Description Usage Arguments Value Author(s) References See Also Examples
The function for calculating the probability of passing critical quality attributes (CQA) PPQ test .
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Llim |
lower specification limit |
Ulim |
upper specification limit |
mu |
hypothetical mean of the attribute |
sigma |
hypothetical standard deviation of the attribute |
n |
sample size (number of locations) per batch |
n.batch |
number of batches for passing PPQ during validation |
alpha |
significant level for constructing the tolerance interval |
coverprob |
coverage probability for constructing the tolerance interval |
side |
whether a 1-sided or 2-sided tolerance interval is required (determined by side = 1 or side = 2, respectively). |
A numeric value of the passing/acceptance probability
Yalin Zhu
Burdick, R. K., LeBlond, D. J., Pfahler, L. B., Quiroz, J., Sidor, L., Vukovinsky, K., & Zhang, L. (2017). Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry. Springer.
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