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

By Honghui Zhou, Frank-Peter Theil

With an emphasis at the primary and useful features of ADME for healing proteins, this booklet 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 functional 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 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 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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Additional resources for ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins: Applications in Drug Discovery and Development

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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. A general strategy for random insertion and substitution mutagenesis: substoichiometric coupling of trinucleotide phosphoramidites. Proc Natl Acad Sci U S A 1992;89:3581–3585.

B) Schematic of IgG molecule showing derivation of the major antibody fragments. Color scheme is as for (a). The fragments shown are the Fab (fragment antigen binding), the scFv (single‐chain variable fragment), the dsFv (disulfide‐linked variable fragment), and the VH/VL (variable heavy/variable light, single domains). ) 16 PROTEIN ENGINEERING: APPLICATIONS TO THERAPEUTIC PROTEINS AND ANTIBODIES improved antigen binding, cross‐reactivity between species or increased stability. This selection for improvements enables the use of random sequence modifications to introduce variation into the library, such as those generated by error‐prone PCR [22].

MAbs 2011;3:415–416. [3] Czajkowsky DM, Hu J, Shao Z, Pleass RJ. Fc‐fusion proteins: new developments and future prospects. EMBO Mol Med 2012;10:1015–1028. [4] Almagro JC, Fransson J. Humanization of antibodies. Front Biosci 2008;13:1619–1633. [5] Palmer E. 2014. The 10 best selling drugs of 2013. Fierce pharma. com/special‐ reports/10‐best‐selling‐drugs‐2013. Accessed 2015 Jun 3. [6] Berman HM, Westbrook J, Feng Z, Gilliland G, Bhat TN, Weissig H, Shindyalov IN, Bourne PE. The Protein Data Bank.

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