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.
View time: 2:40 mins
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.
In this conference report we discuss our highlights from the 10th Open Meeting of the European Bioanalytical Forum – a New Journey begins (Barcelona, Spain; 14–17 November).
In this installment of Robert MacNeill’s (Envigo) column, Robert discusses the instability of drugs within samples and how to balance their instability against absorptive loss.
In this series we will be discovering what immunogenicity is, why it is important and how is it regulated and standardized.
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.
Pfizer’s proposed biosimilar, epoetin alfa, has secured approval from the Oncologic Drugs Advisory Committee becoming a step closer to potential FDA approval.
Alzheimer’s researchers have urged the FDA to update drug approval standards for Alzheimer’s drugs, in the hope to encourage research and scientific progress.
The authors demonstrate how the relationship between academia and not-for-profit organizations with large pharma and emerging biotech companies has shifted toward a more collaborative effort in bringing new therapies to the forefront.
LC–MS quantification of protein drugs: validating protein LC–MS methods with predigestion immunocapture
The purpose of this paper is to describe validation experiments that measure immunocapture efficiency, digestion efficiency, matrix effect and selectivity/specificity that can be used during method optimization and validation to test the resistance of the method to these potential interferences. The designs and benefits of these experiments are discussed in this report using an actual assay case study.