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