Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines

• 主要な著者: Hasumati Rahalkar (著者), Hacer Coskun Cetintas (著者), Sam Salek (著者)
• フォーマット: 図書
• 出版事項: Frontiers Media S.A., 2018-09-01T00:00:00Z.
• 主題: article
• オンライン･アクセス: Connect to this object online.

Objective: The aim was to critically evaluate well-established regulatory agencies mAb biosimilar guidelines for development and marketing authorization about quality, efficacy and safety and compare to BRICS-TM regulations to identify challenges.Materials and Methods: The current valid guidelines o...