extract_from_ll_wcsl

The function <code>extract_from_ll_wcsl()</code> extracts specific elements from
a list of lists returned by the <code>get_wcs_limit()</code> function.

internal

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 

extract_from_ll_wcsl function

<dl><dt>ll</dt>
<dd>A list of lists returned by the <code>get_wcs_limit()</code>
function. The list must have four elements named <code>"cics"</code>,
<code>"dics"</code>, <code>dids.pmse</code> and <code>"dids"</code>. Each of these elements
has a sub-list of the same length as the number of intercepts. And each
of these elements has a sub-sub-list of the same length as the number of
release limits (<code>rl</code>).</dd>
<dt>element</dt>
<dd>A character string that specifies the element to be extracted,
i.e. either one of <code>"delta.lim"</code>, <code>"delta.lim.orig"</code>,
<code>"wcs.lim"</code> or <code>"wcs.lim.orig"</code>.</dd></dl>

Arguments

Extract information from &#8220;worst case scenario&#8221; (wcs) limit lists list — extract_from_ll_wcsl

<dl>

<dt>ll</dt>
<dd>A list of lists returned by the <code>get_wcs_limit()</code>
function. The list must have four elements named <code>"cics"</code>,
<code>"dics"</code>, <code>dids.pmse</code> and <code>"dids"</code>. Each of these elements
has a sub-list of the same length as the number of intercepts. And each
of these elements has a sub-sub-list of the same length as the number of
release limits (<code>rl</code>).</dd>


<dt>element</dt>
<dd>A character string that specifies the element to be extracted,
i.e. either one of <code>"delta.lim"</code>, <code>"delta.lim.orig"</code>,
<code>"wcs.lim"</code> or <code>"wcs.lim.orig"</code>.</dd>

</dl>

extract_from_ll_wcsl: Extract information from “worst case scenario” (wcs) limit lists list

Description

Usage

Value

Arguments

Details

See Also