Publication year: 2022
ISBN: 1119523214
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The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more
Subject: Chemistry, Pharmaceutical & Medicinal Chemistry, Biopharmaceuticals & Pharmaceutical Biotechnology, Biological Products - analysis, Biological Products - therapeutic use, Biological Assay - methods