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An Introduction to Bioanalysis of Biopharmaceuticals (Paperback, 1st ed. 2022)
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An Introduction to Bioanalysis of Biopharmaceuticals (Paperback, 1st ed. 2022)
Series: AAPS Advances in the Pharmaceutical Sciences Series, 57
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The book provides a comprehensive review of the fundamental and
practical aspects of bioanalytical support and the integral role it
plays in the development of safe and efficacious biopharmaceutical
drugs with speed and cost-effectiveness. The book focuses on a
broad range of conventional and emerging biopharmaceutical
modalities including monoclonal antibody-based therapeutics, gene
therapy, cell therapy, peptides and oligonucleotides. Â The
book starts with an introductory overview of bioanalysis showcasing
the integral role it plays in understanding the drug disposition
(pharmacokinetics/pharmacodynamics and immunogenicity) and the
progression of bioanalytical strategy as the drug progresses
through discovery and development stages of the program, taking
into consideration the continually evolving regulatory landscape.
 The book further diversifies into individual
biopharmaceutical modalities - monoclonal antibodies, antibody-drug
conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell
therapies, peptides and oligonucleotides. The individual
chapters focus on modality-specific bioanalytical assay
strategies, critical reagents, assay formats, analytical
platforms, associated bioanalytical challenges and mitigation
strategies, industry best practices, and the latest understanding
of regulatory guidance as applicable to the fast-growing
biopharmaceutical landscape.
General
Imprint: |
Springer Nature Switzerland AG
|
Country of origin: |
Switzerland |
Series: |
AAPS Advances in the Pharmaceutical Sciences Series, 57 |
Release date: |
July 2023 |
First published: |
2022 |
Editors: |
Seema Kumar
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Dimensions: |
235 x 155mm (L x W) |
Format: |
Paperback
|
Pages: |
215 |
Edition: |
1st ed. 2022 |
ISBN-13: |
978-3-03-099998-8 |
Categories: |
Books
Promotions
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LSN: |
3-03-099998-X |
Barcode: |
9783030999988 |
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