scaledBound

It calculates widened bound for scaled average bioequivalence.

Analyze bioequivalence study data with industrial strength. Sample size could be determined for various crossover designs, such as 2x2 design, 2x4 design, 4x4 design, Balaam design, Two-sequence dual design, and William design.
Reference: Chow SC, Liu JP. Design and Analysis of Bioavailability and Bioequivalence Studies. 3rd ed. (2009, ISBN:978-1-58488-668-6).

Kyun-Seop Bae

Bioequivalence Study Data Analysis

scaledBound function

<dl> <dt>CV</dt>
<dd>coefficient of variation in percent</dd> <dt>k</dt>
<dd>0.76 is for EMA and Korea MFDS. US FDA uses 0.893. When CV is 30%, bound becomes (0.8, 1.25). Most regulartory body does not use a more accurate value.</dd>
 
 <dt>digits</dt>
<dd>Korea MFDS use 4 digits only, while other regulatory bodies use more decimal values.</dd></dl>

Arguments

Author

Widened Bound for Scaled Average Bioequivalence — scaledBound

<dl>

 <dt>CV</dt>
<dd>coefficient of variation in percent</dd>

 <dt>k</dt>
<dd>0.76 is for EMA and Korea MFDS. US FDA uses 0.893. When CV is 30%, bound becomes (0.8, 1.25). Most regulartory body does not use a more accurate value.</dd>
 
 <dt>digits</dt>
<dd>Korea MFDS use 4 digits only, while other regulatory bodies use more decimal values.</dd>

</dl>

scaledBound: Widened Bound for Scaled Average Bioequivalence

Description

Usage

Value

Arguments

Author

Details

Examples