Download e-book for kindle: ADME and Translational Pharmacokinetics / Pharmacodynamics by Honghui Zhou, Frank-Peter Theil

By Honghui Zhou, Frank-Peter Theil

ISBN-10: 1118898648

ISBN-13: 9781118898642

With an emphasis at the basic and functional features of ADME for healing proteins, this e-book 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 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 medications in united states, ecu, and Japan
• Provides mechanistic perception into biodistribution and target-driven pharmacokinetics in vital websites of motion resembling tumors and the brain

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

Sample text

17] Prueksaritanont T, Ma B, Tang C, Meng Y, Assang C, Lu P, et al. Metabolic interactions between mibefradil and HMG‐CoA reductase inhibitors: an in vitro investigation with human liver preparations. Br J Clin Pharmacol 1999;47:291–298. [18] Ingelman‐Sundberg M. Implications of polymorphic cytochrome P450‐dependent drug metabolism for drug development. Drug Metab Dispos 2001;29:570–573. [19] Shiran MR, Proctor NJ, Howgate EM, Rowland‐Yeo K, Tucker GT, Rostami‐Hodjegan A. Prediction of metabolic drug clearance in humans: in vitro‐in vivo extrapolation vs allometric scaling.

Each V‐region consists of frameworks onto which are attached the CDRs; these are structural loops (three from variable heavy (VH) and three from ­variable light (VL)), which are largely responsible for antigen binding. The Fc region confers the effector function of the molecule through its interactions with Fc receptors on cells. These functions include ADCC (antibody‐dependent cellular cytotoxicity), CDC (complement‐dependent cytotoxicity), and ADCP (antibody‐dependent cellular phagocytosis), and the Fc also mediates catabolic salvage through FcRn.

ADME of biologics‐what have we learned from small molecules? AAPS J 2012;14:410–419. [34] Wang W, Prueksaritanont T. Prediction of human clearance of therapeutic proteins: simple allometric scaling method revisited. Biopharm Drug Dispos 2010;31:253–263. [35] Vugmeyster Y, Szklut P, Wensel D, Ross J, Xu X, Awwad M, et al. Complex pharmacokinetics of a humanized antibody against human amyloid beta peptide, anti‐abeta ab2, in nonclinical species. Pharm Res 2011;28:1696–1706. [36] Black RS, Sperling RA, Safirstein B, Motter RN, Pallay A, Nichols A, Grundman M.

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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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