acyl glucuronides;
advanced method development;
bioanalytical guidelines;
ISR;
ISR criteria;
ISR failure;
unstable metabolites;
US FDA;
White Paper in bioanalysis;
BIOANALYTICAL METHOD DEVELOPMENT;
VALIDATION GROUP WORKSHOP;
REGULATED BIOANALYSIS;
RECENT ISSUES;
WHITE PAPER;
CALIBRATION;
D O I:
10.4155/BIO.11.22
中图分类号:
Q5 [生物化学];
学科分类号:
071010 ;
081704 ;
摘要:
...our determination to develop a robust, scientifically sound and high-quality method, as well as our employees' professionalism and our quality system, keep us away from incurred sample reanalysis failures.
机构:
Eli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USAEli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USA
Lee, Lisa B.
Wickremsinhe, Enaksha R.
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机构:
Eli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USAEli Lilly & Co, Lilly Corp Ctr, Lilly Res Labs, Indianapolis, IN 46285 USA
机构:
Roche Innovat Ctr New York, Pharmaceut Res & Early Dev Roche Innovat Ctr, New York, NY 10016 USARoche Innovat Ctr New York, Pharmaceut Res & Early Dev Roche Innovat Ctr, New York, NY 10016 USA