The dataset is a bioequivalence dataset from a fully repicated 2x4 crossover design with RTRT and TRTR as sequences. 
It is a subset of Example 4.4 in Chapter 4 of Patterson and Jones's book.

dataset

A likelihood method is implemented to present evidence for evaluating bioequivalence (BE). The functions use bioequivalence data [area under the blood concentration-time curve (AUC) and peak concentration (Cmax)] from various crossover designs commonly used in BE studies including a fully replicated, a partially replicated design, and a conventional 2x2 crossover design. They will calculate the profile likelihoods for the mean difference, total standard deviation ratio, and within subject standard deviation ratio for a test and a reference drug. A plot of a standardized profile likelihood can be generated along with the maximum likelihood estimate and likelihood intervals, which present evidence for bioequivalence. See Liping Du and Leena Choi (2015) <doi:10.1002/pst.1661>.

Liping Du

BElikelihood

Likelihood Method for Evaluating Bioequivalence

Leena Choi

Cole Beck

dat function

A data frame with 176 observations (from 44 subjects) on 6 variables:<dl>
 <dt>subject</dt>
<dd>subject ID</dd> <dt>sequence</dt>
<dd>RTRT or TRTR, where T and R stand for test and reference drugs, respectively</dd> <dt>period</dt>
<dd>1 to 4 for crossover period</dd> <dt>formula</dt>
<dd>T or R stand for test and reference drugs, respectively</dd> <dt>AUC</dt>
<dd>a pharmacokinetic parameter - the area under the blood/plasma concentration-time curve</dd> <dt>CMAX</dt>
<dd>a pharmacokinetic parameter - the peak concentration</dd>
</dl>

Format

Data example for bioequivalence (BE) study — dat

A data frame with 176 observations (from 44 subjects) on 6 variables:<dl>
 <dt>subject</dt>
<dd>subject ID</dd>

 <dt>sequence</dt>
<dd>RTRT or TRTR, where T and R stand for test and reference drugs, respectively</dd>

 <dt>period</dt>
<dd>1 to 4 for crossover period</dd>

 <dt>formula</dt>
<dd>T or R stand for test and reference drugs, respectively</dd>

 <dt>AUC</dt>
<dd>a pharmacokinetic parameter - the area under the blood/plasma concentration-time curve</dd>

 <dt>CMAX</dt>
<dd>a pharmacokinetic parameter - the peak concentration</dd>


</dl>

dat: Data example for bioequivalence (BE) study

Description

Usage

Arguments

Format

Examples