Toward decision-based acceptance criteria for Bioanalytical Method Validation: a proposal for discussion from the European Bioanalysis Forum

被引：11
作者：
Timmerman, Philip [1 ]
Golob, Michaela [2 ]
Goodman, Joanne [3 ]
Knutsson, Magnus [4 ]
Nelson, Robert [5 ]
Fjording, Marianne Scheel [6 ]
White, Steve [7 ]
机构：
[1] European Bioanal Forum, Havenlaan 86c B204, B-1000 Brussels, Belgium
[2] Nuvisan, Grafing, Germany
[3] MedImmune, Cambridge, England
[4] Ferring, Copenhagen, Denmark
[5] Novimmune, Geneva, Switzerland
[6] Novo Nordisk, Malov, Denmark
[7] GlaxoSmithKline, Ware, Herts, England
来源：
BIOANALYSIS | 2018年 / 10卷 / 16期
关键词：
BIOAVAILABILITY; IMPLEMENTATION; BIOEQUIVALENCE; HARMONIZATION; SUPPORT;
D O I：
10.4155/bio-2018-0131
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
[No abstract available]
引用
收藏
页码：1255 / 1259
页数：5
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