Monoclonal antibodies for veterinary use: specific questions to be addressed by the Ad Hoc Expert Group on Veterinary Novel Therapies (ADVENT)
Current version |
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Reference number | EMA/CVMP/ADVENT/307606/2017 |
Published | 11/12/2017 |
Effective from | 07/12/2017 |
Keywords | veterinary, 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 |
| In operation: 07/12/2017-present
Published: 26/02/2016 |