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Viac informácií o knihe Biosimilarity

• Parametre knihy
• Anotácia kniha
• Obľúbené z iného súdka

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Anotácia knihy

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 biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars.

Features:

First comprehensive analysis based on new guidelines and approval packages of several biosimilars

Presents the first approach to challenge FDA in reducing or eliminating any testing in patients.

Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines

Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies

Allow creation of a fast-to-market pathway to develop biosimilars

Parametre knihy

• Celý názov: Biosimilarity
• Podnázov: The FDA Perspective
• Autor: Niazi, Sarfaraz K. (Therapeutic Proteins International, LLC, Chicago, Illinois, USA)
• Jazyk: Angličtina
• Väzba: Brožovaná
• Počet strán: 436
• EAN: 9781032652351
• ID: 44404654
• Nakladateľ: Taylor & Francis Ltd
• Hmotnosť: 802 g
• Rozmery: 254 × 178 mm
• Dátum vydania: 02. October 2023

Obľúbené z iného súdka

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