Investigation of Inter-Individual Variability in Monoclonal Antibody Disposition
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Substantial inter-individual variability (IIV) in monoclonal antibody (mAb) pharmacokinetics has been reported in the clinic. The sources of variability are not well understood and often not explored. Very few preclinical and clinical studies have attempted to examine the sources of IIV. Preclinical investigations, using appropriate mouse models, may allow detailed, mechanistic investigation of possible sources of IIV. The overall objective of this dissertation is to examine putative mechanistic determinants of mAb disposition, identify the sources of variability, elucidate the possible physiological mechanisms involved, and quantify their influence on mAb disposition.