Indexé dans
- Base de données des revues académiques
- Ouvrir la porte J
- Genamics JournalSeek
- Clés académiques
- JournalTOCs
- Infrastructure nationale des connaissances en Chine (CNKI)
- CiteFactor
- Scimago
- Répertoire des périodiques d'Ulrich
- Bibliothèque des revues électroniques
- RechercheRef
- Université Hamdard
- EBSCO AZ
- OCLC - WorldCat
- Catalogue en ligne SWB
- Bibliothèque virtuelle de biologie (vifabio)
- Publions
- MIAR
- Commission des bourses universitaires
- Fondation genevoise pour la formation et la recherche médicales
- Pub européen
- Google Scholar
Liens utiles
Partager cette page
Dépliant de journal
Revues en libre accès
- Agriculture et aquaculture
- Alimentation et nutrition
- Biochimie
- Bioinformatique et biologie des systèmes
- Business & Management
- Chimie
- Génétique et biologie moléculaire
- Immunologie & Microbiologie
- Ingénierie
- La science des matériaux
- Neurosciences & Psychologie
- Science générale
- Sciences cliniques
- Sciences environnementales
- Sciences médicales
- Sciences pharmaceutiques
- Sciences vétérinaires
- Soins infirmiers et soins de santé
Abstrait
Quantitative Evaluation of Bioequivalence/Biosimilarity
Shein-Chung Chow
As more biologic products are going off patent protection, the development of follow-on biologics (biosimilars) products has received much attention from both biotechnology industry and the regulatory agencies. Unlike traditional small-molecule (chemical) drug products, the development of biologic products is very different and variable with respect to the manufacturing process and environment. The complexity and heterogeneity of the molecular structure, complicated manufacturing process, different analytical methods, and possibility of severe immunogenicity reactions make quantitative evaluation of follow-on biologics a great challenge to both scientific community and regulatory agencies. In this article, an overview of current criteria, study design, and statistical methods for quantitative evaluation of bioequivalence for the traditional small molecule generic drug productsand biosimilarity for biosimilars products is provided. In addition, a general approach for development of a biosimilarity index based on the concept of reproducibility probability for quantitative evaluation of bioequivalence/biosimilarity is proposed. Some scientific factors and practical issues are also discussed.