436 Pages
by
CRC Press
436 Pages
79 Color Illustrations
by
CRC Press
436 Pages
79 Color Illustrations
by
CRC Press
Also available as eBook on:
Summary: 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... Read more
Current Status of Biosimilar Biological Products. The FDA Position. Biosimilarity Tetrahedron. Analytical and Functionality Similarity. Non-clinical Assessment. Clinical Pharmacology Assessment. Clinical Studies. Interchangeability Status. Comprehensive Presentation
Biography
Sarfaraz K. Niazi Ph.D, is Adjunct Professor at the faculty of University of Houston as well Chairman and President of Therapeutic Proteins Inc.
