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.
Browsing: Journal Articles
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.
Learn more about a new robust method by which to measure sodium, potassium and creatine levels with clear improvements over some established methodology in this article from Bioanalysis.
Quantification of serum purine metabolites for distinguishing patients with hepatitis B from hepatocellular carcinoma
Discover how UPLC-MS/MS can be used to measure purine metabolites and how this may contribute to differential diagnosis of HBV-I and HCC in this research article from Bioanalysis.
2019 White Paper on recent issues in bioanalysis: Part 3 – FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation
Part three of the White Paper published in Bioanalysis from the 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) covers the FDA immunogenicity guidance, gene therapy, critical reagents, biomarkers and flow cytometry validation.
Electromembrane extraction of substances with weakly basic properties: a fundamental study with benzodiazepines
In this article from Bioanalysis, researchers investigated an electromembrane extraction method for weakly basic benzodiazepines. Results from the electromembrane extraction method followed by UHPLC-MS/MS analysis for human plasma samples were in compliance with EMA guidelines.
Development and evaluation of an ultrasensitive free VEGF-A immunoassay for analysis of human aqueous humor
Learn more about the highly sensitive immunoassay designed to detect baseline VEGF-A levels in this research article from Bioanalysis.
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.