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CRC Press - Biosimilar Drug Product Development Book

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Description

Navigating the complexities of biological drug patent expiration requires a deep understanding of alternative product development. Biosimilar Drug Product Development provides a comprehensive guide for professionals working in the pharmaceutical sciences. This resource addresses the specific challenges involved when developing biosimilar products, offering clarity on the many steps and considerations required for success. This text covers the assessment of biosimilarity and interchangeability, which are often difficult and complicated processes. Readers will find detailed reviews of various development stages and the factors that influence them. By exploring relevant regulatory pathways and addressing both pre- and post-approval issues, this book serves as a vital resource for those in pharmacy, drug development, and allied health professions. Whether you are studying pharmaceutical sciences or working in industry, this guide offers the technical insight needed to understand the current landscape of biosimilar drug development.

Key Features

Detailed reviews of the various stages and contributing factors involved in the development of biosimilar products.

In-depth analysis of the complicated processes used to assess biosimilarity and interchangeability.

Comprehensive coverage of relevant regulatory pathways for biosimilar drug development.

Practical guidance on managing both pre-approval and post-approval issues in the pharmaceutical industry.

Expert insights into the current issues facing the development of biosimilar drugs following patent expiration.

Product Specifications

Format
hardcover
Domain
Amazon UK
Release Date
07 March 2017
Listed Since
07 October 2016

Barcode

No barcode data available

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