Constructing an Immunogenicity Risk Assessment for Follow-On Biologics
| Autor: | Anthony Mire-Sluis, Paul Chamberlain |
|---|---|
| Rok vydání: | 2005 |
| Předmět: |
Computer science
Immunogenicity Comparability Pharmaceutical Science Pharmacology Variety (cybernetics) 03 medical and health sciences Reference product 0302 clinical medicine Biopharmaceutical Risk analysis (engineering) Component (UML) 030212 general & internal medicine Product (category theory) Risk assessment 030217 neurology & neurosurgery |
| Zdroj: | Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector. 2:133-144 |
| ISSN: | 1741-7090 1741-1343 |
| Popis: | The registration of follow-on biologics will depend on the availability of data demonstrating comparability with a reference product. It is recognised that measurement of relative immunogenicity will be an important component of the product comparability assessment. The way in which this is done will depend on a multidimensional risk-based approach that considers the probability of generating an immune response relative to the consequences of such a response. This paper presents principles and practical guidance for constructing a risk assessment, building on the experience gained for a variety of biopharmaceutical products. This includes the use of preclinical models and validated bioanalytical methods. Ultimately, post-marketing monitoring will be required to evaluate more fully the risk in representative settings, given the multifactorial nature of the potential immunogenicity of different therapeutic proteins. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
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