HPE Drug stability: What do we need to know? | Page 17

FIGURE 1
Stability in solutions screen: Rituximab monograph
pictographic information and it is translated into
29 languages (including all European languages and
Arabic, Japanese, Vietnamese and Chinese). Stabilis ®
contains 461 monographs of injectable drugs, each
monograph containing six screens including a
screen entitled ‘Stability in solutions’ (see Figure 1).
Most of the monographs include stability studies
from hospital pharmacy teams or academics with
extended stability studies in comparison with
the information given by the manufacturers.
Sometimes, long term stability is provided up to six
months.
On this screen (rows 6 and 9), it can be seen
that rituximab is stable for 180 days at 1mg/ml in
0.9% sodium chloride (green triangle). By clicking
on the reference number 3241, the user can view
the bibliographic reference with details on the
analytical methods and other information on the
study. The letter in the right hand side column gives
the level of evidence of the article (A, B, C or D).
For this publication, A is the level obtained and the
highest level of evidence (Figure 2). The translation
of the pictogram into the user-specific language is
immediately available by hovering the cursor over it.
On lines 1–5 and 7, a pictogram of a monoclonal
immunoglobulin indicates ‘biosimilar’, which
indicates that the stability study was not carried out
with the originator.
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