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

By Honghui Zhou, Frank-Peter Theil

ISBN-10: 1118898648

ISBN-13: 9781118898642

With an emphasis at the basic and sensible elements of ADME for healing proteins, this publication is helping readers strategize, plan and enforce translational study 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 sensible 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, european, and Japan
• Provides mechanistic perception into biodistribution and target-driven pharmacokinetics in vital websites of motion reminiscent of 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

Sample text

Rapid Commun Mass Spectrom 2005;19:843–848. [26] Korfmacher WA. Use of mass spectrometry for drug metabolism studies. Curr Drug Metab 2006;7:455–563. [27] Plumb R, Castro‐Perez J, Granger J, Beattie I, Joncour K, Wright A. Ultra‐performance liquid chromatography coupled to quadrupole‐orthogonal time‐of‐flight mass spectrometry. Rapid Commun Mass Spectrom 2004;18:2331–2337. [28] Prueksaritanont T, Chu X, Gibson C, Cui D, Yee KL, Ballard J, Cabalu T, Hochman J. Drug–drug interaction studies: regulatory guidance and an industry perspective.

Another method was to use double‐stranded oligonucleotide cassettes, made by annealing complementary mutation‐containing oligonucleotides and ligating them between restriction sites, either naturally occurring or introduced “silently” into the sequence through a previous round of mutagenesis [8, 9]. Although efficient as long as sites for high‐fidelity restriction enzymes could be used, this method was limited by the length of oligonucleotide that could be accurately synthesized and purified, usually in the range of 60–80 bases.

Proc Natl Acad Sci USA 1994;91: 10747–10751. [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.

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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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