The Critical Path Institute (AZ, USA) have announced support from the European Medicines Agency (London, UK) for the measurement of glutamate dehydrogenase as a biomarker of hepatocellular live injury.
Biosimilar trastuzumab candidate (CT-P6) shown to be similar in efficacy and safety to the reference trastuzumab in data presented at the 2017 American Society of Clinical Oncology Annual Meeting (IN, USA).
In this article the China Bioanalytical Forum (CBF) provides an update on the Chinese bioanalytical regulatory landscape, discussing the emergence of recent changes in regulated bioanalysis.
Scientific or regulated validation: a tiered approach? Meeting report from a joint EBF/DVDMDG workshop
This conference report presents a summary of discussions between the Delaware Valley Drug Metabolism Discussion Group and the EBF on the tiered approach.
In this commentary, Stacy Ho (Sanofi) outlines how regulatory agency expectations have profound effects on laboratory practices and data quality.
New US FDA draft guidance on bioanalytical method validation versus current FDA and EMA guidelines: chromatographic methods and ISR
This Commentary provides an overview of the US FDA draft guidance on bioanalytical method validation, and compares the draft with the FDA guidance from 2001, as well as the EMA guidelines on bioanalytical method validation published in 2011.
8th Workshop on Recent Issues in Bioanalysis – where regulators and industry convene – March 2014, Los Angeles/Universal City, California
The workshop has been split into 3 main sessions.
This review outlines an array of topics relevant to 2D LC–MS, including its fundamental principles and bioanalytical applications.
This article outlines the recommendations proposed at the 5th/6th GCC Closed Forum on biomarker bioanalytical method validation.
Conference Report: 6th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars
This Conference Report deals with a variety of topics discussed at the 6th GCC Closed Forum on current bioanalytical interests, EMA recommendations and co-administered drugs stability.