Description Usage Arguments Value Author(s) References See Also Examples
The function for plotting the OC curves and optimizing the baseline and high performance PPQ plans, given lower and upper specification limits.
1 | pi_occurve(attr.name, attr.unit, Llim, Ulim, mu, sigma, n, n.batch, alpha, add.reference)
|
attr.name |
user-defined attribute name |
attr.unit |
user-defined attribute unit |
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. |
add.reference |
logical; if |
OC curves for specification test and PPQ plan.
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.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 | ## Not run:
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01))
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01), n.batch=3)
# Baseline curve
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01), alpha = 0.1135434)
# High performance curve
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01), alpha = 0.0225518)
# 95% with reference curves
pi_occurve(attr.name = "Total Protein", attr.unit = "mg/mL",
sigma = seq(0.01,1,0.01), add.reference=TRUE)
pi_occurve(attr.name = "Composite Assay", attr.unit = "%",
mu = 100, sigma = seq(0.1,6,0.1), Llim=95, Ulim=105, n.batch=1, add.reference=TRUE)
pi_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%",
mu=97, sigma=seq(0.1, 10, 0.1), Llim=95, Ulim=105, n=10, add.reference=TRUE)
pi_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%",
mu=100, sigma=seq(0.1, 10, 0.1), Llim=95, Ulim=105, n=10, add.reference=TRUE)
pi_occurve(attr.name = "Sterile Concentration Assay", attr.unit="%",
mu=seq(95,105,0.1), sigma=1, Llim=95, Ulim=105, n=10, add.reference=TRUE)
pi_occurve(attr.name = "Protein Concentration", attr.unit="%",
mu=seq(90, 110, 0.1), sigma=1.25, Llim=90, Ulim=110, add.reference=TRUE)
## End(Not run)
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