Biosimilars: Critical Quality Attributes

Описание к видео Biosimilars: Critical Quality Attributes

What are critical quality attributes? This video discusses Comparative analytical studies between the proposed biosimilar and its reference product that comprehensively evaluate structural and functional characteristics called critical quality attributes. These are attributes that can impact the overall quality and clinical performance of the product. For more information, visit www.FDA.gov/biosimilars.

Комментарии

Информация по комментариям в разработке