Key considerations in the preclinical development of biosimilars
| Autor: | Beverly Ingram, Chee-Keng Ng, Lynne A. Bui, Ira Jacobs, Anne M. Ryan, Carol F. Kirchhoff, Susan Hurst, Gregory L. Finch |
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| Rok vydání: | 2014 |
| Předmět: |
Pharmacology
Quality Control Consumer Product Safety Therapeutic equivalency Drug Industry Molecular Structure Process (engineering) business.industry Manufacturing process Drug Evaluation Preclinical Guidance documents Biosimilar Nanotechnology Structure-Activity Relationship Risk analysis (engineering) Therapeutic Equivalency Risk Factors Drug Discovery Key (cryptography) Medicine Animals Humans business Biosimilar Pharmaceuticals |
| Zdroj: | Drug discovery today. 20 |
| ISSN: | 1878-5832 |
| Popis: | Biosimilar development requires several steps: selection of an appropriate reference biologic, understanding the key molecular attributes of that reference biologic and development of a manufacturing process to match these attributes of the reference biologic product. The European Medicines Agency (EMA) and the FDA guidance documents state that, in lieu of conducting extensive preclinical and clinical studies typically required for approval of novel biologics, biosimilars must undergo a rigorous similarity evaluation. The aim of this article is to increase understanding of the preclinical development and evaluation process for biosimilars, as required by the regulatory agencies, that precedes the clinical testing of biosimilars in humans. |
| Databáze: | OpenAIRE |
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