By Honghui Zhou, Frank-Peter Theil
With an emphasis at the basic and useful elements of ADME for healing proteins, this ebook is helping readers strategize, plan and enforce translational learn for biologic drugs.
• Details state-of-the-art ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs
• Combines theoretical with useful elements of ADME in biologic drug discovery and improvement and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned viewpoint
• Includes case stories approximately leveraging ADME to enhance biologics drug improvement for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines
• Presents regulatory expectancies and views for constructing biologic medicines in united states, european, and Japan
• Provides mechanistic perception into biodistribution and target-driven pharmacokinetics in very important websites of motion corresponding to tumors and the brain
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Extra info for ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins: Applications in Drug Discovery and Development
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In this way, the molecule can “piggy‐back” to albumin to achieve antibody‐ like serum retention without any of the properties of the Fc. Another solution is to use PEGylation. Certolizumab pegol consists of a Fab′ fragment engineered to have a single free cysteine in its hinge region to which a PEG moiety is site‐ specifically conjugated. The PEG moiety is thought to create a large hydrodynamic water shell around the Fab fragment, which prevents kidney filtration and may reduce its tendency to diffuse out of normal blood but results in efficient tissue penetration at sites of inflammation .