Biosimilarity: The FDA Perspective - CRC Press Book - Image 1

£89.83

CRC Press Biosimilarity: The FDA Perspective - CRC Press Book

Name: Biosimilarity: The FDA Perspective - CRC Press Book
Brand: CRC Press
Price: 94.02 GBP
Availability: InStock

Biomedical Engineering

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Description

Navigate the complex landscape of biological drug approval with Biosimilarity: The FDA Perspective. Published by CRC Press, this book offers a deep look into how the U.S. FDA approaches the approval process for biosimilar drugs. By analyzing recent FDA approvals, it provides a practical guide for understanding the regulatory environment. This resource explains how to use statutory limits and non-inferiority testing to help avoid unnecessary patient trials and reduce the need for extensive immunogenicity testing. It provides the mathematical and statistical foundations necessary to establish biosimilarity across various levels of biological complexity. Whether you are a researcher or a developer, this text serves as a vital technical resource for meeting modern regulatory standards and understanding the scientific tools required for successful drug development.

Key Features

Provides a comprehensive analysis based on the latest FDA guidelines and recent approval packages.

Explains how to use non-inferiority testing and statutory limits to minimize the need for patient trials.

Offers an in-depth scientific and mathematical view of the tools required to establish biosimilarity.

Covers the statistical methods needed to manage biological drugs of different complexity levels.

Delivers practical insights learned directly from recent U.S. FDA drug approval processes.

Product Specifications

Brand: CRC Press
Format: hardcover
ASIN: 1498750397
Category: Books > Subjects > Health, Family & Lifestyle > Medical & Healthcare Practitioners > Allied Health Professions > Biomedical Engineering
Domain: Amazon UK
Release Date: 04 August 2016
Listed Since: 04 November 2015

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CRC Press Biosimilarity: The FDA Perspective - CRC Press Book

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