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   Articles with "ich m10" as a keyword



Feedback from a workshop by the European Bioanalysis Forum on assay validation requirements for in vitro assays following the publication of ICH M12 guideline - a plea for context-of-use over ICH M10 standards.

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recommendations! Published in 2025 at "Bioanalysis"

DOI: 10.1080/17576180.2025.2468596

Abstract: The release of the ICH M12 Guideline on Drug Interaction Studies has reignited discussions around assay validation requirements for in vitro assays such as plasma protein-binding studies. Even though the ICH M12 does not directly… read more here.

Keywords: validation requirements; ich m12; validation; ich m10 ... See more keywords

Perspectives on the draft ICH-M10 guidance: an interview with Eric J Woolf.

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recommendations! Published in 2019 at "Bioanalysis"

DOI: 10.4155/bio-2019-0178

Abstract: Biography Dr Woolf is currently Executive Director of the regulated PK Bioanalysis Group of Merck Research Laboratories, West Point, PA, USA. He received his BA in Chemistry from LaSalle College in 1982, and a PhD in Analytical Chemistry… read more here.

Keywords: research; bioanalysis; interview; chemistry ... See more keywords

European Bioanalysis Forum feedback on draft ICH M10 guideline on bioanalytical method validation during the Step 2b public consultation period.

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recommendations! Published in 2020 at "Bioanalysis"

DOI: 10.4155/bio-2020-0065

Abstract: Once released, the ICH M10 Guideline on bioanalytical method validation will become one of the most important milestones in the history of regulated bioanalysis, closing a chapter on intense discussions among the industry and health… read more here.

Keywords: bioanalysis; bioanalytical method; guideline bioanalytical; method validation ... See more keywords

Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline.

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recommendations! Published in 2023 at "Bioanalysis"

DOI: 10.4155/bio-2022-0229

Abstract: In this report, the European Bioanalysis Forum shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop. The focus of the discussions… read more here.

Keywords: harmonized implementation; guideline; ich m10; implementation ... See more keywords