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The US Food and Drug Administration (FDA) have announced a final guidance for industry, ’Bioanalytical Method Validation,’ is now available.
Browsing: Regulated bioanalysis
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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.
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