Introduction to Biologic and Biosimilar Product Development and Analysis
โ Scribed by Karen M. Nagel
- Publisher
- Springer International Publishing
- Year
- 2018
- Tongue
- English
- Leaves
- 116
- Series
- AAPS Introductions in the Pharmaceutical Sciences
- Edition
- 1st ed.
- Category
- Library
No coin nor oath required. For personal study only.
โฆ Synopsis
The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery. In order to maintain a limited focus, Introduction to Biologic and Biosimilar Product Development and Analysis, will deal only with peptides, proteins and monoclonal antibodies.
โฆ Table of Contents
Front Matter ....Pages i-xi
Principles of Recombinant DNA Technology (Karen M. Nagel)....Pages 1-29
Therapeutic Proteins (Karen M. Nagel)....Pages 31-54
Therapeutic Antibodies (Karen M. Nagel)....Pages 55-86
Analysis and Regulation of Biologics, Including Biosimilars (Karen M. Nagel)....Pages 87-97
Back Matter ....Pages 99-109
โฆ Subjects
Biomedicine; Pharmaceutical Sciences/Technology; Pharmacy
๐ SIMILAR VOLUMES
"This is the first book entirely devoted to the design and analysis for assessment of biosimilarity and drug interchangeability of biosimilars, and test for comparability in manufacturing processes of biologic products. It covers all of the statistical issues that may occur in biosimilar studies u
<p>As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator`s biologic products. But scientific chal
<P>When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. <B><EM>Biosimilar D
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<p><span>Methodologies for Biosimilar Product Development</span><span> covers the practical and challenging issues that are commonly encountered during the development, review, and approval of a proposed biosimilar product. These practical and challenging issues include, but are not limited to the m