In this feature we assess the global bioanalytical landscape in light of the draft ICH M10 bioanalytical method validation guideline published in 2019. Explore the impact of the draft guidance document through a selection of exclusive Bioanalysis journal and Bioanalysis Zone content.
Browsing: ICH M10
In this interview, Mark Arnold (Covance, NJ, USA) discusses the scope of the draft ICH M10 guidance as well as explaining the difference between full, partial and cross validation and how to choose which validation to use and when.
In this interview, Eric Woolf (Merck; PA, USA) provides an overview of the draft ICH M10 guidance for bioanalytical method validation, indicating why there is a need for new guidance and discussing possible disadvantages of such a collective consensus guidance.
In this editorial from Bioanalysis, a collection of experts from CROs across the globe provide a CRO perspective on the potential impact of the ICH M10 guidance.
In this interview, John Kadavil (FDA, MD, USA) discusses what he expected from the draft ICH M10 guidance and speculates on the potential challenges that may be encountered as laboratories begin to implement the new guidance.
In this interview, Kelly Dong (United-Power Pharma Tech Co., Beijing, China) describes recent developments in the Chinese regulatory landscape. Dong also explains how industry in China will collate feedback with regards to the draft ICH M10.
In this supplement from Bioanalysis, the European Bioanalysis Forum reports its feedback to the ICH on the ICH M10 bioanalytical method validation draft guideline gathered during the public consultation period.
In this interview, Boris Gorovits (Pfizer, MA, USA) gives his thoughts on how the draft ICH M10 guidance will differ from current BMV guidance. Gorovits also speculates how the ICH M10 could change the bioanalytical regulatory landscape.
In this commentary from Bioanalysis, authors discuss the evolution of bioanalytical method validation guideline language, tracking changes through references to BMV guidance in Bioanalyis journal over the past decade.
2019 White Paper on recent issues in bioanalysis: FDA BMV guidance, ICH M10 BMV guideline and regulatory inputs (Part 2 – recommendations on 2018 FDA BMV guidance, 2019 ICH M10 BMV draft guideline and regulatory agencies’ input on bioanalysis, biomarkers and immunogenicity)
Part two of the White Paper published in Bioanalysis from the 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) covers the FDA BMV guidance and the ICH M10 BMV Guideline and Regulatory inputs.