Monoclonal antibodies for veterinary use: specific questions to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)

Current version

PDF iconQuestions and Answers

Reference number

EMA/CVMP/ADVENT/307606/2017

Published11/12/2017
Effective from07/12/2017
Keywordsveterinary, monoclonal antibody
Description

The guidance, in the form of a question-and-answer document, relates to particularities of monoclonal antibodies for veterinary use, such as quality control for potential contaminants, stability testing, reproductive safety studies and data to address potential for indirect adverse effects.


Document history

First version
Current version

PDF iconQuestions and answers

PDF iconProblem statement

In operation: 07/12/2017-present

Published: 26/02/2016


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