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Other literature type . 2025
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https://dx.doi.org/10.58079/15...
Other literature type . 2025
Data sources: Datacite
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EMA – Public consultation: Draft guideline on quality aspects of phage therapy medicinal products

descriptionPublicationkeyboard_double_arrow_right Other literature type 01 Jan 2025Publisher:ELSIBI
Authors: vroby;

doi: 10.58079/15buu

handle: 20.500.13089/15buu

EMA – Public consultation: Draft guideline on quality aspects of phage therapy medicinal products

Abstract

The aim of this guideline is to clarify the regulatory expectations for quality documentation of bacteriophage active substances and finished products for human use within marketing authorisation applications. It addresses specific aspects regarding the manufacture, control of materials, characterisation, specifications, analytical control, reference standards and stability of bacteriophage active substances. In addition, guidance is given on the pharmaceutical development, manufacture, control...

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
bronze