| Type: | Package |
| Title: | Finite Sample Correction of the Two One-Sided Tests in the Univariate Framework |
| Version: | 1.0.1 |
| Maintainer: | Younes Boulaguiem <younes.boulaguiem@gmail.com> |
| Description: | A system containing easy-to-use tools to compute the bioequivalence assessment in the univariate framework using the methods proposed in Boulaguiem et al. (2023) <doi:10.1101/2023.03.11.532179>. |
| Depends: | PowerTOST, cli, knitr, R (≥ 4.0) |
| Imports: | rmarkdown |
| Suggests: | asciicast |
| License: | AGPL-3 |
| Encoding: | UTF-8 |
| LazyData: | true |
| RoxygenNote: | 7.2.3 |
| VignetteBuilder: | knitr |
| URL: | https://github.com/yboulag/cTOST |
| BugReports: | https://github.com/yboulag/cTOST/issues |
| NeedsCompilation: | no |
| Packaged: | 2025-02-10 11:03:02 UTC; yobo19 |
| Author: | Younes Boulaguiem [aut, cre, cph], Stéphane Guerrier [aut, cph], Dominique-Laurent Couturier [aut, cph] |
| Repository: | CRAN |
| Date/Publication: | 2025-02-10 11:20:05 UTC |
Get Corrected Level
Description
This function applies the alpha-TOST corrective procedure to obtain the corrected level.
Usage
alphahat.fun(sigma, nu, alpha, delta, tol = 1e-07)
Arguments
sigma |
A |
nu |
A |
alpha |
A |
delta |
A |
tol |
A |
Author(s)
Younes Boulaguiem, Stéphane Guerrier, Dominique-Laurent Couturier
The alpha-TOST Corrective Procedure for (Bio)Equivalence Testing
Description
This functions is used to compute the alpha-TOST, a corrective procedure of the significance level applied to the Two One-Sided Test (TOST) for (bio)equivalence testing in the univariate framework.
Usage
atost(theta, sigma, nu, alpha, delta)
Arguments
theta |
A |
sigma |
A |
nu |
A |
alpha |
A |
delta |
A |
Value
A tost object with the structure:
decision: A boolean variable indicating whether (bio)equivalence is accepted or not.
ci: Confidence interval at the 1 - 2*alpha level.
theta: The difference of means used for the test.
sigma: The standard error used for the test.
nu: The number of degrees of freedom used for the test.
alpha: The significance level used for the test.
delta: The (bio)equivalence limits used for the test.
method: The method used for the test (here the "alpha-TOST").
Author(s)
Younes Boulaguiem, Stéphane Guerrier, Dominique-Laurent Couturier
Examples
data(skin)
theta_hat = diff(apply(skin,2,mean))
nu = nrow(skin) - 1
sig_hat = sd(apply(skin,1,diff))/sqrt(nu)
res_atost = atost(theta = theta_hat, sigma = sig_hat, nu = nu,
alpha = 0.05, delta = log(1.25))
res_atost
compare_to_tost(res_atost)
Confidence Intervals
Description
Confidence Intervals
Usage
ci(alpha, theta, sigma_nu, nu, ...)
Arguments
alpha |
A |
theta |
A |
sigma_nu |
A |
nu |
A |
... |
Additional parameters. |
Value
The function returns a numerical vector with the lower and upper bound of the confidence intervals.
Author(s)
Younes Boulaguiem, Stéphane Guerrier, Dominique-Laurent Couturier
Comparison of a Corrective Procedure to the results of the Two One-Sided Tests (TOST)
Description
This function renders a comparison of the alpha-TOST or the delta-TOST outputs obtained with the functions 'atost' or 'dtost', respectively, to the TOST output obtained with 'tost'.
Usage
compare_to_tost(x, ticks = 30, rn = 5)
Arguments
x |
A |
ticks |
an integer indicating the number of segments that will be printed to represent the confidence intervals. |
rn |
integer indicating the number of decimals places to be used (see function 'round') for the printed results. |
Value
Pints a comparison between the TOST results (i.e., output of 'tost') and either the alpha-TOST or the delta-TOST results (i.e., outputs of 'atost' or 'dtost', respectively).
Get Corrected (Bio)Equivalence Bounds
Description
This function applies the delta-TOST corrective procedure to obtain the corrected (bio)equivalence bounds
Usage
deltahat.fun(sigma, alpha, delta, nu)
Arguments
sigma |
A |
alpha |
A |
delta |
A |
nu |
A |
The delta-TOST Corrective Procedure for (Bio)Equivalence Testing
Description
This functions is used to compute the delta-TOST, a corrective procedure of the (bio)equivalence bounds applied to the Two One-Sided Test (TOST) for (bio)equivalence testing in the univariate framework.
Usage
dtost(theta, sigma, nu, alpha, delta)
Arguments
theta |
A |
sigma |
A |
nu |
A |
alpha |
A |
delta |
A |
Value
A tost object with the structure:
decision: A boolean variable indicating whether (bio)equivalence is accepted or not.
ci: Confidence interval at the 1 - 2*alpha level.
theta: The difference of means used for the test.
sigma: The standard error used for the test.
nu: The number of degrees of freedom used for the test.
alpha: The significance level used for the test.
delta: The (bio)equivalence limits used for the test.
method: The method used for the test (here the "delta-TOST").
Author(s)
Younes Boulaguiem, Stéphane Guerrier, Dominique-Laurent Couturier
Examples
data(skin)
theta_hat = diff(apply(skin,2,mean))
nu = nrow(skin) - 1
sig_hat = sd(apply(skin,1,diff))/sqrt(nu)
res_dtost = dtost(theta = theta_hat, sigma = sig_hat, nu = nu,
alpha = 0.05, delta = log(1.25))
res_dtost
compare_to_tost(res_dtost)
Get alpha star
Description
Get alpha star
Usage
get_alpha_star(alpha, sigma_nu, nu, delta, ...)
Arguments
alpha |
A |
sigma_nu |
A |
nu |
A |
delta |
A |
... |
Additional parameters. |
Value
The function returns a numeric value that corresponds to the solution of the optimisation.
Author(s)
Younes Boulaguiem, Stéphane Guerrier, Dominique-Laurent Couturier
Objective function to optimise
Description
Objective function to optimise
Usage
obj_fun_alpha_star(test, alpha, sigma_nu, nu, delta, ...)
Arguments
test |
A |
alpha |
A |
sigma_nu |
A |
nu |
A |
delta |
A |
... |
Additional parameters. |
Value
The function returns a numeric value for the objective function.
Author(s)
Younes Boulaguiem, Stéphane Guerrier, Dominique-Laurent Couturier
Objective Function of the delta-TOST Corrective Procedure
Description
Objective Function of the delta-TOST Corrective Procedure
Usage
obj_fun_delta_hat(delta_star, sigma, alpha, delta, nu)
Arguments
delta_star |
The (bio)equivalence bound parameter to be optimized. |
sigma |
The considered standard error. |
alpha |
The nominal level for the test. |
delta |
The (bio)equivalence bound used for the TOST decision. |
nu |
The degrees of freedom parameter. |
Power function
Description
Power function
Usage
power_TOST(alpha, theta, sigma, nu, delta, ...)
Arguments
alpha |
A |
theta |
A |
sigma |
A |
nu |
A |
delta |
A |
... |
Additional parameters. |
Value
The function returns a numeric value that corresponds to a probability.
Author(s)
Younes Boulaguiem, Stéphane Guerrier, Dominique-Laurent Couturier
Print Results of (Bio)Equivalence Assessment
Description
Print Results of (Bio)Equivalence Assessment
Usage
## S3 method for class 'tost'
print(x, ticks = 30, rn = 5, ...)
Arguments
x |
A |
ticks |
Number of ticks to print the confidence interval in the console. |
rn |
Number of digits to consider when printing the results. |
... |
Further arguments to be passed to or from methods. |
Value
Prints object.
The size
Description
The size
Usage
size_TOST(alpha, sigma_nu, nu, delta, ...)
Arguments
alpha |
A |
sigma_nu |
A |
nu |
A |
delta |
A |
... |
Additional parameters. |
Value
The function returns a numeric value that corresponds to a probability.
Author(s)
Younes Boulaguiem, Stéphane Guerrier, Dominique-Laurent Couturier
Log transformed cutaneous delivery of econazole (ECZ) from bioequivalent products on porcine skin
Description
Original data were collected in the same way as described in Quariter et. al. (2019), and represents cutaneous delivery of econazole nitrate (ECZ in ng/cm^2) on porcine skin from a reference medicinal product and an approved bioequivalent product. The dataset contains 17 pairs of comparable porcine skin samples on which measurement of ECZ deposition was gathered, and log transformed, using both creams.
Usage
data(skin)
Format
A 'data.frame' with 16 rows and 2 columns:
- Reference
Econazole nitrate delivery for the reference product.
- Generic
Econazole nitrate delivery for the generic bioequivalent product.
- Obs.
The observation corresponds to a given skin on which the log ECZ delivery was collected for each of the reference and generic cream.
References
Quartier, Julie, et al. "Cutaneous Biodistribution: A High-Resolution Methodology to Assess Bioequivalence in Topical Skin Delivery", Pharmaceutics, (2019). Boulaguiem, Younes, et al. "Finite Sample Adjustments for Average Equivalence Testing", Statistics in Medicine, (2023)
Examples
data(skin)
theta <- diff(apply(skin,2,mean))
nu <- nrow(skin)-1
sigma_nu <- sd(apply(skin,1,diff))/sqrt(nu)
Two One-Sided Test (TOST) for (Bio)Equivalence Testing
Description
This function performs a Two One-Sided Test (TOST) for (bio)equivalence testing.
Usage
tost(theta, sigma, nu, alpha, delta)
Arguments
theta |
A |
sigma |
A |
nu |
A |
alpha |
A |
delta |
A |
Value
A tost object with the structure:
decision: A boolean variable indicating whether (bio)equivalence is accepted or not.
ci: Confidence interval at the 1 - 2*alpha level.
theta: The difference of means used for the test.
sigma: The standard error used for the test.
nu: The number of degrees of freedom used for the test.
alpha: The significance level used for the test.
delta: The (bio)equivalence limits used for the test.
method: The method used for the test (here the "TOST").
Author(s)
Younes Boulaguiem, Stéphane Guerrier, Dominique-Laurent Couturier
Examples
data(skin)
theta_hat = diff(apply(skin,2,mean))
nu = nrow(skin) - 1
sig_hat = sd(apply(skin,1,diff))/sqrt(nu)
tost(theta = theta_hat, sigma = sig_hat, nu = nu,
alpha = 0.05, delta = log(1.25))