`R/pi_occurve.R`

`pi_occurve.Rd`

The function for plotting the OC curves and optimizing the baseline and high performance PPQ plans, given lower and upper specification limits.

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.

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*.

`pi_pp`

and `rl_pp`

.

Yalin Zhu

if (FALSE) { 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) }