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

By Honghui Zhou, Frank-Peter Theil

With an emphasis at the primary and useful points 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 standpoint
• Includes case reports 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, european, and Japan
• Provides mechanistic perception into biodistribution and target-driven pharmacokinetics in very important websites of motion equivalent to tumors and the brain

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

Example text

Display technologies, first described by Smith in the form of phage display of peptides through their (a) Fv 15 incorporation as a fusion into the sequence of the phage gene III protein [20], have become increasingly important. The key to the technology is the physical link between the genotype, the DNA within the phage particle, and the phenotype, the property conferred by the peptide or protein displayed on the surface of the phage particle. This linkage facilitates sequence determination of the displayed molecule following selection of the phage through the specific binding property.

20] Smith GP. Filamentous fusion phage: novel expression vectors that display cloned antigens on the virion surface. Science 1985;228:1315–1317. [21] Harris LJ, Larson SB, Hasel KW, Day J, Greenwood A, McPherson A. The three‐dimensional structure of an intact monoclonal antibody for canine lymphoma. Nature 1992; 360:369–372. [22] Hawkins RE, Russell SJ, Winter G. Selection of phage antibodies by binding affinity. Mimicking affinity maturation. J Mol Biol 1992;226:889–896. [23] Sondek J, Shortle D.

It will be interesting to see whether these molecules, which can have advantages in terms of expression, stability, and reduced size (and hence perhaps improved tissue penetration), can find a therapeutic niche. As more antibody sequences are analyzed on the back of Next Generation Sequencing technologies, as more antibody structures are solved, and as molecular modeling and sequence/structure prediction software improves, the impact of protein engineering can only increase further. There is also the prospect that in silico prediction of properties from protein sequence, including propensity to aggregate, efficiency of expression, and immunogenicity, will provide further protein engineering opportunities.

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