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

Assessment for statistically-based PPQ sampling plan, including calculating the passing probability, optimizing the baseline and high performance cutoff points, visualizing the PPQ plan and power dynamically. The analytical idea is based on the simulation methods from the textbook Burdick, R. K., LeBlond, D. J., Pfahler, L. B., Quiroz, J., Sidor, L., Vukovinsky, K., & Zhang, L. (2017). Statistical Methods for CMC Applications. In Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry (pp. 227-250). Springer, Cham.

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biostatisticspharmaceuticalssampling-methods

4.11 score 1 stars 13 scripts 231 downloads

MHTdiscrete - Multiple Hypotheses Testing for Discrete Data

A comprehensive tool for almost all existing multiple testing methods for discrete data. The package also provides some novel multiple testing procedures controlling FWER/FDR for discrete data. Given discrete p-values and their domains, the [method].p.adjust function returns adjusted p-values, which can be used to compare with the nominal significant level alpha and make decisions. For users' convenience, the functions also provide the output option for printing decision rules.

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adjustment-computationsbenjamini-hochbergbonferronidiscrete-distributionsmultiple-testing-correction

3.27 score 1 stars 37 scripts 196 downloads

FixSeqMTP - Fixed Sequence Multiple Testing Procedures

Several generalized / directional Fixed Sequence Multiple Testing Procedures (FSMTPs) are developed for testing a sequence of pre-ordered hypotheses while controlling the FWER, FDR and Directional Error (mdFWER). All three FWER controlling generalized FSMTPs are designed under arbitrary dependence, which allow any number of acceptances. Two FDR controlling generalized FSMTPs are respectively designed under arbitrary dependence and independence, which allow more but a given number of acceptances. Two mdFWER controlling directional FSMTPs are respectively designed under arbitrary dependence and independence, which can also make directional decisions based on the signs of the test statistics. The main functions for each proposed generalized / directional FSMTPs are designed to calculate adjusted p-values and critical values, respectively. For users' convenience, the functions also provide the output option for printing decision rules.

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multiple-testingpre-ordersequential-testing

3.22 score 3 stars 11 scripts 196 downloads

ADCT - Adaptive Design in Clinical Trials

Existing adaptive design methods in clinical trials. The package includes power, stopping boundaries (sample size) calculation functions for two-group group sequential designs, adaptive design with coprimary endpoints, biomarker-informed adaptive design, etc.

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3.00 score 5 scripts 243 downloads

MHTmult - Multiple Hypotheses Testing for Multiple Families/Groups Structure

A Comprehensive tool for almost all existing multiple testing methods for multiple families. The package summarizes the existing methods for multiple families multiple testing procedures (MTPs) such as double FDR, group Benjamini-Hochberg (GBH) procedure and average FDR controlling procedure. The package also provides some novel multiple testing procedures using selective inference idea.

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hierarchical-datamultiple-testingmultiplicity

2.70 score 9 scripts 187 downloads

ph2mult - Phase II Clinical Trial Design for Multinomial Endpoints

Provide multinomial design methods under intersection-union test (IUT) and union-intersection test (UIT) scheme for Phase II trial. The design types include : Minimax (minimize the maximum sample size), Optimal (minimize the expected sample size), Admissible (minimize the Bayesian risk) and Maxpower (maximize the exact power level).

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1.48 score 1 dependents 6 scripts 148 downloads