TRR.RTR

rds22

<p>Dataset simulated to be evaluated by <code>method.A()</code>, <code>method.B()</code>.</p>

datasets

Performs comparative bioavailability calculations for Average
Bioequivalence with Expanding Limits (ABEL). Implemented are 'Method A' /
'Method B' and the detection of outliers. If the design allows, assessment
of the empiric Type I Error and iteratively adjusting alpha to control the
consumer risk. Average Bioequivalence - optionally with a tighter (narrow
therapeutic index drugs) or wider acceptance range (South Africa: Cmax) -
is implemented as well.

Helmut Schuetz

replicateBE

Average Bioequivalence with Expanding Limits (ABEL)

Helmut Sch<c3><bc>tz

Michael Tomashevskiy

Detlew Labes

TRR.RTR function

<p></p><ul>
<li><p>Reference dataset 22
    Simulated with  =  = 45%,  =  = 100% GMR 0.90. 42 subjects.
    Balanced (21 subjects in each of the sequences) and complete (no missing data). No outliers.
    A data frame with 126 observations on the following 5 variables:</p><dl class="dl-horizontal">
      <dt>rds22</dt><dd><p><table><tr><td>
        <code>subject</code> </td>
<td> a factor with 42 levels: 1, 2, &#8230;, 42</td>
</tr><tr><td>
        <code>period</code> </td>
<td> a factor with 3 levels: 1, 2, 3</td>
</tr><tr><td>
        <code>sequence</code> </td>
<td> a factor with 2 levels: TRR, RTR</td>
</tr><tr><td>
        <code>treatment</code> </td>
<td> a factor with 2 levels: T, R</td>
</tr><tr><td>
        <code>PK</code> </td>
<td> a numeric vector of pharmacokinetic responses acceptable for reference-scaling (generally )</td>
</tr></table></p></dd>
    </dl></li>
</ul>

Format

Reference Dataset for TRR|RTR (extra-reference) Designs — TRR.RTR

<p></p><ul>
<li><p>Reference dataset 22
    Simulated with  =  = 45%,  =  = 100% GMR 0.90. 42 subjects.
    Balanced (21 subjects in each of the sequences) and complete (no missing data). No outliers.
    A data frame with 126 observations on the following 5 variables:</p><dl class='dl-horizontal'>
      <dt>rds22</dt><dd><p><table><tr><td>
        <code>subject</code> </td>
<td> a factor with 42 levels: 1, 2, &#8230;, 42</td>
</tr><tr><td>
        <code>period</code> </td>
<td> a factor with 3 levels: 1, 2, 3</td>
</tr><tr><td>
        <code>sequence</code> </td>
<td> a factor with 2 levels: TRR, RTR</td>
</tr><tr><td>
        <code>treatment</code> </td>
<td> a factor with 2 levels: T, R</td>
</tr><tr><td>
        <code>PK</code> </td>
<td> a numeric vector of pharmacokinetic responses acceptable for reference-scaling (generally )</td>
</tr></table></p></dd>
    </dl></li>
</ul>

`subject`	a factor with 42 levels: 1, 2, …, 42
`period`	a factor with 3 levels: 1, 2, 3
`sequence`	a factor with 2 levels: TRR, RTR
`treatment`	a factor with 2 levels: T, R
`PK`	a numeric vector of pharmacokinetic responses acceptable for reference-scaling (generally )

TRR.RTR: Reference Dataset for TRR|RTR (extra-reference) Designs

Description

Usage

Arguments

Format

Details

Examples