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).
Browsing: Regulated bioanalysis
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.
In this special report from Bioanalysis , the authors report on the importance of physiologically relevant quantitative bioanalytical assays. They share experiences from project support (internal and at CROs) that suggests the need to be ever vigilant translating the needs of bioanalysis with those of project teams.
2016 White Paper on recent issues in bioanalysis: focus on biomarker assay validation (BAV) (Part 1 – small molecules, peptides and small molecule biomarkers by LCMS)
This 2016 White Paper encompasses recommendations emerging from the extensive discussions held during this years 10th Workshop on Recent Issues in Bioanalysis (10th WRIB) which took place in Orlando, Florida earlier this year. The report is aimed to provide the bioanalytical community with key information and practical solutions on topics and issues addressed, in an effort to enable advances in scientific excellence, improved quality and better regulatory compliance. This part (Part 1) discusses the recommendations for small molecules, peptides and small molecule biomarkers by LC–MS
In this commentary, the author aims to provide some clarity on accuracy-related expectations for the regulated bioanalysis of ‘endogenous’ analytes.
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.
A simple, effective approach for rapid development of high-throughput and reliable LC–MS/MS bioanalytical assays
In this article, the authors describe a simple, effective approach to achieve accelerated method development of high-throughput and reliable LC–MS/MS assays for regulated bioanalysis.