ADME and Translational Pharmacokinetics/ Pharmacodynamics of Therapeutic proteins: Applications in Drug Discovery and Development.
ADME and Translational Pharmacokinetics/ Pharmacodynamics of Therapeutic proteins: Applications in Drug Discovery and Development
Edited by Honghui Zhou and Frank-Peter Theil
Pharmaceutical researchers from the US, Europe, and Asia offer 27 chapters on the ADME (absorption, distribution, metabolism, and excretion) and translational pharmacokinetics/pharmacodynamics of therapeutic proteins, particularly monoclonal proteins. They report on ADME research and small molecule drugs; the applications of protein engineering to therapeutic proteins and antibodies; protein engineering to influence ADME, pharmacokinetics, and efficacy; antibody-derived proteins and proteins with novel scaffolds; antibody-drug conjugates; the role of the lymphatic system in subcutaneous absorption of therapeutic proteins; biodistribution; the prediction of human pharmacokinetics for protein-based biologic therapeutics; fixed dosing vs. body-size-based dosing; the impact of diseases, comorbidity, and target physiology on ADME, pharmacokinetics, and pharmacodynamics; and immunogenicity. Others discuss mechanistic physiologically based pharmacokinetic models in the development of therapeutic monoclonal antibodies; integrated quantitation of biotherapeutic drug-target binding, biomarkers, and clinical response to support rational dose regimen selection; target-driven pharmacokinetics; tumor and brain effect site pharmacokinetics; molecular pathology techniques in the preclinical development of therapeutic biologics; labeling and imaging techniques for quantification; how knowledge of ADME of therapeutic proteins in adults facilitates pediatric development; liquid chromatography mass spectrometry vs. immune-based bioanalytical methods in quantitation; biosimilar development; vaccines; drug development strategies; clinical pharmacology in the development of biologics; a case study of the nonclinical ADME and pharmacokinetics/pharmacodynamics of an antibody-drug conjugate; and the use of pharmacokinetics/pharmacodynamics knowledge in guiding bispecific biologics research and development. ([umlaut] Ringgold, Inc., Portland, OR)