In this interview, John Kadavil (US FDA; MA, USA) shares his thoughts on the draft ICH M10 guidance for bioanalytical method validation, indicating how this will change the bioanalytical regulatory landscape.
Browsing: Regulated bioanalysis
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 despite many BMV guidance currently being available.
Richard Hucker (A4P Codescribes key trends, challenges and what the future may hold for bioanalytical outsourcing.
Best practices in performing flow cytometry in a regulated environment: feedback from experience within the European Bioanalysis Forum
In this manuscript, the European Bioanalysis Forum presents additional practice guidance on the use of flow cytometry in the support of drug development programs and addresses areas that are not covered in the previous publications.
Read time: 00:30 mins
The US Food and Drug Administration (FDA) have announced a final guidance for industry, ’Bioanalytical Method Validation,’ is now available.
View time: 2:40 mins
We interview Vera Hillewaert, Scientist at Janssen Research & Development (NJ, USA), who discusses her research and the impact of rules and regulations.
Implementing a tiered approach to bioanalytical method validation for large-molecule ligand-binding assay methods in pharmacokinetic assessments
Bioanalytical methods must enable the delivery of data that meet sound, scientifically justified, fit-for-purpose criteria. This perspective piece highlights three tiers of method validation – regulatory, scientific and research validations. The criteria for selecting the appropriate application of each of these PK method validation workflows are discussed.
The Good Clinical Laboratory Practice accreditation will enable the company to extend its proteomic services to the analysis of clinical trial samples.
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).
The FDA have approved Merck’s blockbuster drug Keytruda (pembrolizumab) to treat solid tumors on the basis of genetic characteristics rather than specific type and location.