By Randall J. Mrsny, Ann Daugherty
Addressing the elevated use of protein and peptide applicants as remedies for formerly untreatable ailments, this complete and innovative resource presents the reader with a roadmap to an elevated figuring out of matters severe for effectively constructing a protein or peptide healing candidate. Proteins and Peptides is a useful resource for drug discovery and improvement scientists within the biopharmaceutical who usually navigate the maze of protein and peptide pharmacokinetics, pharmacodynamics, and metabolism. Key positive factors contain:
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Additional resources for Proteins and Peptides: Pharmacokinetic, Pharmacodynamic, and Metabolic Outcomes (Drugs and the Pharmaceutical Sciences)
Example text
The results were consistent with the in vitro results, suggesting that anti-CD11a clearance in vivo was driven by receptor-mediated internalization and lysosomal degradation by cells expressing CD11a (40). Fcg Receptor Binding Correlated to Antibody Pharmacokinetics Nearly every cell type of the immune system expresses FcgRs, including B lymphocytes, dendritic cells, macrophages, natural killer (NK) cells, neutrophils, mast cells, platelets, Langerhans cells, eosinophils, mesangial cells, and endothelial cells (41).
Modeling tools have been developed to predict the in vivo PK solely based on in vitro and in silico ADME data together with established physiological information required to describe the mammalian body (4,5). This concept of predicting human PK on the basis of in vitro and in silico data using mechanistic PBPK models has been successfully implemented in the realm of drug discovery and development, thereby partly replacing empirical prediction methods. The establishment of IVIVC derived from mechanistic models has resulted in a somewhat paradigm shift in that the human PK of SMD is now predicted primarily on the basis of in vitro and in silico data, whereas in vivo data from preclinical animal species are rather used to verify prediction success as surrogate for human prior to the actual prediction of human PK.
Correlation of in vivo PD exclusively to in vitro binding is a somewhat rare scenario, as most studies tend to also examine the in vitro potency. One of the few examples is TRX1, a nondepleting humanized antihuman CD4 monoclonal IgG1 Ab being developed to induce tolerance by blocking CD4-mediated functions (93). Ng et al. related TRX1-induced internalization of CD4 and subcellular localization of T cell internalized TRX1 Ab in human T cells to the in vivo downmodulation of CD4 and clearance of TRX1 (93).