Download 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 elements 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 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 point of view
• Includes case reviews 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 medicinal drugs in united states, ecu, and Japan
• Provides mechanistic perception into biodistribution and target-driven pharmacokinetics in very important websites of motion comparable 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

Sample text

The domain structure of the antibody molecule also lends itself to other engineered formats designed to achieve new modalities, such as bispecificity. Several approaches have been taken to promote heavy‐ chain heterodimer formation, including a “knobs into holes” method [79] and a method exploiting the phenomenon of Fab‐arm exchange [80]. Other approaches aim to combine IgG with additional smaller antigen‐binding fragments fused to the C‐terminus of heavy or light chain [81]. It is beyond the scope of this chapter to describe in full this plethora of bispecific strategies, but they do serve to highlight the power of protein engineering techniques to create Ig‐based novel molecules to achieve new therapeutic modalities.

J Pharmacokinet Pharmacodyn 2001;28:507–532. [63] Levy G. Pharmacologic target‐mediated drug disposition. Clin Pharmacol Ther 1994;56:248–252. [64] Zhou H, Mascelli MA. Mechanisms of monoclonal ­antibody‐drug interactions. Annu Rev Pharmacol Toxicol 2011;51:359–372. [65] Lee JI, Zhang L, Men AY, Kenna LA, Huang SM. CYP‐mediated therapeutic protein‐drug interactions clinical findings, proposed mechanisms and regulatory implications. Clin Pharmacokinet 2010;49:295–310. [66] Girish S, Martin SW, Peterson MC, Zhang LK, Zhao H, Balthasar J, et al.

This would be particularly impactful for hard‐to‐immunize targets. There is still a major drive to produce medicines with improved efficacy, greater safety, reduced immunogenicity, and improved stability. Optimizing drug disposition by improved in vivo ADME behavior remains an important focus of protein engineering to obtain protein structures, which provide functional behavior resulting into beneficial efficacy and limiting safety issues. The following chapter REFERENCES illustrates some specific protein engineering techniques with special application toward improving drug disposition.

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