Article
The Principle of Homologous Groups in Regulatory Affairs of Allergen Products – A Proposal
12 Aug 2008
Abstract excerpt
Among other legal regulations, the Note for Guidance on Allergen Products CPMP/BWP/243/96 released by the European Medicines Agency provides regulatory instructions regarding the quality of allergen extracts for diagnostic or therapeutic purposes. The current revision of this guideline intends to transform the so-called 'principle of taxonomic families' to the 'principle of homologous groups'. According to this...
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