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Ph. Eur. on acellular pertussis vaccines: Histamine Sensitisation Test proposed for replacement

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European Pharmacopoeia
General text/chapter
News
13 April 2018
Strasbourg, France

Acellular pertussis vaccines: replacement test on miceThe European Pharmacopoeia (Ph. Eur.) Commission is seeking public feedback on its proposal to replace the Histamine sensitisation test in mice (HIST) with a standardised CHO cell clustering assay for residual pertussis toxin testing, in general chapter 2.6.33 Residual pertussis toxin and irreversibility of pertussis toxoid and in ten individual monographs on vaccines containing acellular pertussis.

Published in the April 2018 issue of Pharmeuropa, this consultation will run until June 2018. Interested parties are invited to provide their comments through the Procedure for commenting on Pharmeuropa drafts.

 

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