ti_occurve: Operating Characteristic (OC) Curves for the PPQ Plan using...

In PPQplan: Process Performance Qualification (PPQ) Plans in Chemistry, Manufacturing and Controls (CMC) Statistical Analysis

Description

The function for plotting the OC curve to show the PPQ plan based on the specification test, given lower and upper specification limits.

Usage

ti_occurve(attr.name, attr.unit, Llim, Ulim, mu, sigma, n, n.batch, alpha,
coverprob, side, add.reference, NV)

Arguments

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 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).
add.reference	logical; if TRUE, then add reference OC curves (Baseline and High Performance) in the plot.
NV	nominal volume for the specification test.

Value

OC curves for specification test and PPQ plan.

Author(s)

Yalin Zhu

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

ti_pp and rl_pp.

Examples

## Not run: 
ti_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)

ti_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)

ti_occurve(attr.name = "Extractable Volume", attr.unit = "% of NV=3mL",
Llim = 100, Ulim = Inf, mu=102.5, sigma=seq(0.2, 6 ,0.05), n=40,
alpha = 0.05, coverprob = 0.97, side=1, NV=3)

ti_occurve(attr.name = "Extractable Volume", attr.unit = "% of NV=3mL",
Llim = 100, Ulim = Inf, mu=102.5, sigma=seq(0.2, 6 ,0.05), n=40,
alpha = 0.05, coverprob = 0.992, side=1, NV=3)

## End(Not run)

PPQplan documentation built on Jan. 13, 2021, 9:49 p.m.