exp4

A data set containing the concentration data (mg/kg) of four batches
obtained over a 24 months period of a drug product. A total of \(n = 36\)
independent measurements are available (corresponding to the data set
Reliability/Stability.jmp in JMP(R) 12 Reliability and Survival
Methods manual).

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 

exp4 function

A data frame with 36 observations and 3 variables:<dl>
 <dt>Batch</dt>
<dd>Factor with levels <code>1_11</code>, <code>2_12</code>, <code>3_13</code> and
 <code>4_14</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>Conc</dt>
<dd>Numeric of the measured concentrations in \(mg / kg\).</dd>
</dl>

Format

Stability data of 4 batches — exp4

A data frame with 36 observations and 3 variables:<dl>
 <dt>Batch</dt>
<dd>Factor with levels <code>1_11</code>, <code>2_12</code>, <code>3_13</code> and
 <code>4_14</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>Conc</dt>
<dd>Numeric of the measured concentrations in \(mg / kg\).</dd>


</dl>

exp4: Stability data of 4 batches

Description

Usage

Arguments

Format

References

Examples