Recommendations and feedback from the European Bioanalysis Forum Workshop: 1 year into ICH M10-keeping our finger on the pulse

被引：4

作者：

Timmerman, Philip ^{[1
]}

Barfield, Matthew ^{[2
]}

Portabella, Enric Bertran ^{[3
]}

Calogero, Salvatore ^{[4
]}

Cowan, Kyra ^{[5
]}

Faber, Joerg ^{[6
]}

Ferrari, Luca ^{[7
]}

Golob, Michaela ^{[8
]}

Goodman, Jo ^{[9
]}

Goodwin, Lee ^{[10
]}

Gnoth, Mark Jean ^{[11
]}

Hughes, Richard ^{[12
]}

Ivanova, Tsvetelina ^{[13
]}

Jordan, Gregor ^{[14
]}

Lauren, Anna ^{[15
,16
]}

Maux, Delphine ^{[17
]}

Mcdougall, Stuart ^{[18
]}

Milushewa, Petya ^{[13
]}

Nelson, Robert ^{[19
]}

Pynaert, Gwenda ^{[20
]}

Sklodowski, Kamil ^{[7
]}

Sleigh, Rebecca ^{[12
]}

Struwe, Petra ^{[21
]}

Verhaeghe, Tom ^{[22
]}

Wheller, Robert ^{[12
]}

White, Steve ^{[23
]}

Zeiser, Katja ^{[8
]}

机构：

[1] European Bioanal Forum, Havenlaan 86c b204, B-1000 Brussels, Belgium

[2] Roche Pharm Res & Early Dev, Roche Innovat Ctr Welwyn, Welwyn Garden City AL7 1TW, Herts, England

[3] Moderna Innovat & Technol Ctr, Harwell Sci & Innovat Campus, Oxford OX11 0DF, England

[4] Swiss BioQuant, Biochem Anal, CH-4153 Reinach, BL, Switzerland

[5] Merck KGaA, Res & Dev, Drug Metab & Pharmacokinet New Biol Ent, D-64293 Darmstadt, Germany

[6] A&M Lab Analyt & Metab Forsch Serv GmbH, D-50126 Bergheim, Germany

[7] F Hoffmann La Roche Ltd, Roche Pharm Res & Early Dev pRED, CH-4070 Basel, Switzerland

[8] Nuvisan GmbH, Bioanal, D-89231 Neu-ulm, Germany

[9] AstraZeneca, Integrated Bioanal Clin Pharmacol & Safety Sci, BioPharmaceut R&D, Cambridge CB21 6GH, England

[10] Labcorp, Bioanalyt Serv, Otley Rd, Harrogate HG3 1PY, England

[11] Bayer AG, Bayer, DMPK, Vivo PK & bioanalyt, D-42096 Wuppertal, Germany

[12] Resolian Bioanalyt, Newmarket Rd, Fordham CB7 5WW, England

[13] Comac Med, Qual & Compliance, Sofia 1404, Bulgaria

[14] Roche Diagnost GmbH, Roche Innovat Ctr Munich, Roche Pharm Res & Early Dev pRED, Pharmaceut Sci Bioanal & Biomarkers, Nonnenwald 2, D-82377 Penzberg, Germany

[15] MinervaX, S-22363 Lund, Sweden

[16] Novo Nord AS, Nonclin & Clin Assay Sci, Global Discovery & Dev Sci, Global Drug Discovery, DK-2760 Malov, Denmark

[17] Syneos Hlth Clin Pharmacol & Bioanal, Bioanal, F-06410 Biot, France

[18] Quotient Sci, Bioanalyt Serv, Taylor Dr, Alnwick NE66 2DH, Northumberland, Scotland

[19] BioAgilytix Labs, D-22339 Hamburg, Germany

[20] Argenx BV, Bioanalyt, B-9052 Zwijnaarde, Belgium

[21] Celer Switzerland AG, Bioanalyt Serv, Allmendstr, CH-8320 Fehraltorf, Switzerland

[22] BDDS, J&J Innovat Med, B-2340 Beerse, Belgium

[23] GSK, IVIVT BIB, Gunnells Wood Rd, Stevenage SG1 2NY, England

来源：

BIOANALYSIS | 2024年 / 16卷 / 05期

关键词：

ASSAYS; VALIDATION;

D O I：

10.4155/bio-2024-0013

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

The ICH M10 guideline on bioanalytical method validation and sample analysis is being adopted since 2023. However, and inevitably, some paragraphs or requirements remain ambiguous and are open for different interpretations. In support of a harmonized interpretation by the industry and health authorities, the European Bioanalysis Forum organized a workshop on 14 November 2023 in Barcelona, Spain, to discuss unclear and/or ambiguous paragraphs which were identified by the European Bioanalysis Forum community and delegates of the workshop prior to the workshop. This manuscript reports back from the workshop with recommendations and aims at continuing an open scientific discussion within the industry and with regulators in support of a science-driven guideline for the bioanalytical community and in line with the ICH mission - that is, achieve greater harmonization worldwide to ensure that safe, effective and high-quality medicines are developed and registered in the most resource-efficient manner.

引用

页码：259 / 270

页数：12

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