The function for calculating the probability of passing critical quality attributes (CQA) PPQ test .

pi_pp(Llim, Ulim, mu, sigma, n, n.batch, alpha)

Arguments

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 prediction interval.

Value

A numeric value of the passing/acceptance probability

References

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.

See also

rl_pp.

Author

Yalin Zhu

Examples

if (FALSE) { pi_pp(sigma=0.5, mu=2.5, n=10, n.batch=1, Llim=1.5, Ulim=3.5, alpha=0.05) sapply(X=c(0.1,0.5, 1,2,3,4,5,10), FUN = pi_pp, mu=97, n=10, Llim=95, Ulim=105, n.batch=1, alpha=0.05) sapply(X=c(0.1,0.5, 1,2,3,4,5,10), FUN = pi_pp, mu=100, n=10, Llim=95, Ulim=105, n.batch=1, alpha=0.05) }