Critical role of bioanalytical strategies in investigation of clinical PK observations, a Phase I case study.
第一作者:
Kun,Peng
第一单位:
a Department of BioAnalytical Sciences; Genentech Inc ; South San Francisco , CA USA.
作者:
关键词
5, 5′-tetramethylbenzidine;BSA, bovine serum albuminCDR, complementarity-determining regionELISA, enzyme-linked immunosorbent assayHRP, horseradish peroxidaseIS, internal standardIgG1, immunoglobulin G1LC-MS/MSLC-MS/MS, liquid chromatography tandem mass spectrometryLDL-c, low density lipoprotein cholesterolLDLR, low density lipoprotein receptorLLOQ, lower limit of quantificationMAD, multiple-ascending doseMQC, minimum quantifiable concentrationMRM, multiple reaction monitoringNHS, normal human seraPBS, phosphate buffered salinePCSK9, proprotein convertase subtilisin/kexin type 9;PD, pharmacodynamicsPK, pharmacokineticsRG7652RT, room temperatureS/N, signal-to-noiseSA, streptavidinSAD, single-ascending doseSIL, stable isotope-labeledTMB, 3, 3′clinical pharmacokinetic assayenzyme-linked immunosorbent assaymAbs, monoclonal antibodiesproprotein convertase subtilisin/kexin type 9rhuPCSK9, recombinant human PCSK9signature peptide
主题词
抗体, 单克隆(Antibodies, Monoclonal);色谱法, 液相(Chromatography, Liquid);队列研究(Cohort Studies);剂量效应关系, 药物(Dose-Response Relationship, Drug);双盲法(Double-Blind Method);酶联免疫吸附测定(Enzyme-Linked Immunosorbent Assay);人类(Humans);免疫球蛋白G(Immunoglobulin G);前蛋白转化酶类(Proprotein Convertases);丝氨酸内肽酶类(Serine Endopeptidases);串联质谱法(Tandem Mass Spectrometry)
DOI
10.4161/mabs.36208
PMID
25484037
发布时间
2019-12-10
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