Pharmeuropa
reviews are circulated for information. Pharmeuropa is a free online EDQM
publication. Draft monographs are published in Pharmeuropa for public enquiry,
which lasts for three months. Comments received are processed by EDQM, at this
stage the draft can be amended and republished. If no further revision is
required the draft monograph is proposed to the European Pharmacopoeia
Commission if adopted an implementation date is given and this is about one
year after the adoption of the monograph. The monograph is then published in
the European Pharmacopoeia (or supplement). The monograph is published about 6
months after adoption. Therefore draft text appearing in Pharmeuropa may not
become official for up to 2 years. Those monograph’s adopted will be
highlighted in reviews of the European Pharmacopoeia or supplements
Note:
Pharmeuropa, Pharmeuropa Bio and Pharmeuropa Scientific Notes are available on
line via EDQM web site.
Draft
Monographs and General Texts for Comment:
5.3 Statistical
Analysis of Results of Biological Assays and Tests
Equivalence
testing. It is proposed to include an explicit mention of ‘equivalence testing’
in section 7.6. It is already noted in the introduction that the general
chapter is not mandatory, and that methods that are not described but are
supported by data and agreed by the competent authorities can be used.
Nevertheless, ‘equivalence testing’ is now explicitly mentioned, which may
facilitate consideration of this method by the competent authorities if it is
presented with appropriate supporting documentation.
2.2.3 Potentiometric
Determination of pH
Posted by Tim Sandle
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