Biosimilarity: The FDA Perspective

 

کتابخانه الکترونیکی دیتا ساینس

شناسه: Ebook-04719.1

عنوان: Biosimilarity: The FDA Perspective

قیمت: رایگان

لینک دانلود مستقیم:

The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity.  An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity — a must for every developer of biosimilars.

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