液相质谱生物分析技术在新药研发中的新进展.pdf

Advances in LC-MS bioanalysis for drug research and development 液相质谱生物样品分析技术在新药研发中的新进展 张杰 DMPK, Novartis Institutes for BioMedical Research (诺华), New Jersey 2014南京国际药代会议, June 27-28, 2014 Focused areas in LC-MS bioanalysis in recent years 生物样品定量分析技术热点领域  Global harmonization of bioanalytical practice and new BMV guidance from FDA and EMA 方法验证全球协调 Quantitation of Antibody Drug Conjugate (ADC), Bispecific Antibody (BsMAb), MAb (intact and large fragment characterization, PEGylated), peptides, siRNA, etc. 抗体药物复合物, 多肽及蛋白药物, 短干扰核糖核酸等类的定量分析  Dried Blood Spot (DBS)/microsampling干血斑点/微量样品  Unstable compound bioanalysis, whole blood stability, lipemic plasma matrix effects 不稳定的化合物分析, 全血稳定性, 脂血血浆基质效应  Electronic Laboratory Notebooks (ELN) 电子实验室笔记本  Incurred sample reanalysis/stability (ISR/ISS) 实际样品再分析/稳定性  Biomarker quantification; Fit-for-Purpose validation 生物标志物定量  Free total measurement 非蛋白键合及总和的药物定量  High resolution MS in regulated bioanalysis 高分辨质谱生物定量分析 2 | Nanjing Pharma conference | Jie Zhang | 28-Jun-2014 | | Business Use Only Major meetings and publications in bioanalysis 生物样品分析领域的主要会议和出版物  Conferences/Meetings/Workshops • American Society for Mass Spectrometry (ASMS) Conference on Mass Spectrometry and Allied Topics • Workshop on Recent Issues in Bioanalysis (WRIB) • European Bioanalysis Forum (EBF) Open Symposium • Land O’Lakes Bioanalytical Conference • Applied Pharmaceutical Analysis (APA) • American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition Journals • Bioanalysis • Analytical Chemistry • Journal of Chromatography A/B • Biomedical Chromatography • Rapid Communications in Mass Spectrometry 3 | Nanjing Pharma conference | Jie Zhang | 28-Jun-2014 | | Business Use Only Handbook of LC-MS Bioanalysis 最近二十年来最全面完整的生物样品分析参考书  Edited by Wenkui Li, Jie Zhang Francis Tse (Novartis US) (Wiley in August of 2013)  Key highlights • 70