Biological Drug Products: Development and Strategies
his book overviews the fundamental aspects, challenges, and development strategies for biological drug entities. It is divided into 5 parts, covering general aspects in the development of biologics (Part 1) and challenges and strategies in the development of specific types of biologics (Parts 2-5)....
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| Main Author: | |
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| Other Authors: | |
| Format: | Book |
| Language: | English |
| Published: |
Newdelhi
Wiley
2018
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| Subjects: | |
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| Summary: | his book overviews the fundamental aspects, challenges, and development strategies for biological drug entities. It is divided into 5 parts, covering general aspects in the development of biologics (Part 1) and challenges and strategies in the development of specific types of biologics (Parts 2-5). In the overview section, contributing authors discuss the development process, safety and clinical assessments, manufacturing, and regulatory and intellectual property issues. Following this opening, the major classes of biologics are proteins and peptides, vaccines, oligonucleotides, and gene and regenerative medicines. A concluding section details administration and delivery routes and systems. The book incorporates both lessons learned and future directions to make for a valuable resource and reference for pharmaceutical scientists involved in the dynamic field of biologics. |
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| Physical Description: | xv,728p |
| ISBN: | 9788126577606 |