ADME and Translational Pharmacokinetics / Pharmacodynamics by Honghui Zhou, Frank-Peter Theil PDF

By Honghui Zhou, Frank-Peter Theil

ISBN-10: 1118898648

ISBN-13: 9781118898642

With an emphasis at the primary and sensible features of ADME for healing proteins, this publication 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 points 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 experiences 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 medications in united states, ecu, and Japan
• Provides mechanistic perception into biodistribution and target-driven pharmacokinetics in very important websites of motion akin to tumors and the brain

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Additional resources for ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins: Applications in Drug Discovery and Development

Sample text

Initially, gene synthesis involved synthesizing and annealing complementary oligonucleotides, then ligating through overlapping cohesive ends [17]. Once again, PCR revolutionized the process enabling savings in expense and time, as single‐ stranded oligonucleotides could be annealed and gaps filled with thermo‐stable polymerase before amplification of full length products. Today, most gene synthesis processes can be outsourced to companies specializing in the technique, who can also optimize codons, minimize unwanted secondary structure, and remove cryptic splice sites.

Similarly, deletion of the CH2 and CH3 domains as in some fragments removes the interaction with FcRn giving a much shorter serum retention time. The reduction in size of certain antibody fragments including Fab and smaller molecules, coupled to the absence of the FcRn interaction site, gives a very rapid clearance from blood by the kidneys but also gives much more rapid distribution to the tissues. For instances where monovalent antibody fragments are preferred but where long half‐life is 20 PROTEIN ENGINEERING: APPLICATIONS TO THERAPEUTIC PROTEINS AND ANTIBODIES necessary, an approach other than to use the Fc region can be applied.

A number of methods are available to determine these residues [43–45]. 5). Other methods of humanization have been developed; some are variations of this grafting method while others rely on phage display to select active variants [4]. The technique of “guided selection” is a phage display method that was used to create the therapeutic antibody adalimumab from its hybridoma precursor D2E7 [46]. Phage display is also used for antibody discovery to generate human antibodies directly from naïve human libraries [47].

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ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins: Applications in Drug Discovery and Development by Honghui Zhou, Frank-Peter Theil


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