exp2

A data set containing the related substance stability data (in % of label
claim (LC)) of three batches of a drug product obtained over a 24 months
period. A total of \(n = 24\) independent measurements are available
(corresponding to data shown in Table XI in LeBlond et al. (2011)).

datasets

The Australian Regulatory Guidelines for Prescription
Medicines (ARGPM), guidance on "Stability testing for prescription
medicines", recommends to predict the shelf life of chemically derived
medicines from stability data by taking the worst case situation at batch
release into account. Consequently, if a change over time is observed,
a release limit needs to be specified. Finding a release limit and the
associated shelf life is supported, as well as the standard approach
that is recommended by guidance Q1E "Evaluation of stability data"
from the International Council for Harmonisation (ICH).

Pius Dahinden

expirest

Expiry Estimation Procedures

Tillotts Pharma AG 

exp2 function

A data frame with 48 observations and 3 variables:<dl>
 <dt>Batch</dt>
<dd>Factor with levels <code>b4</code>, <code>b5</code> and <code>b8</code></dd> <dt>Month</dt>
<dd>Numeric representing the time points of testing from the
 start (0 months) to the end (24 months) of the study.</dd> <dt>Related</dt>
<dd>Numeric of the measured related substance levels in %LC</dd>
</dl>

Format

Stability related substance data of three batches — exp2

A data frame with 48 observations and 3 variables:<dl>
 <dt>Batch</dt>
<dd>Factor with levels <code>b4</code>, <code>b5</code> and <code>b8</code></dd>

 <dt>Month</dt>
<dd>Numeric representing the time points of testing from the
 start (0 months) to the end (24 months) of the study.</dd>

 <dt>Related</dt>
<dd>Numeric of the measured related substance levels in %LC</dd>


</dl>

exp2: Stability related substance data of three batches

Description

Usage

Arguments

Format

References

Examples