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Aim: Stability must be evaluated before quantitation of drugs or metabolites concentrations in biological matrices. We reported a case study where instability of a drug metabolite was mediated by hemolysis. Materials & methods: The instability of both enantiomers of N-desethyloxybutynin was observed in hemolyzed plasma stored at -20°C. The investigations indicated that heme-mediated oxidation converted […]

The 2019 13th Workshop on Recent Issues in Bioanalysis (WRIB) took place in New Orleans, LA on 1–5 April 2019 with an attendance of over 1000 representatives from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, week-long event – a full immersion week of bioanalysis, biomarkers, immunogenicity

Over the last decade, there has been broad incorporation of translational biomarkers into the early drug development process to predict safety concerns, measure target engagement and monitor disease progression. One goal of translational biomarkers is to create a cycle whereby preclinical readouts influence candidate selection and subsequent clinical data are fed back into research to

The 2017 11th Workshop on Recent Issues in Bioanalysis (11th WRIB) took place in Los Angeles/Universal City, California from 3 April 2017 to 7 April 2017 with participation of close to 750 professionals from pharmaceutical/biopharmaceutical companies, biotechnology companies, contract research organizations and regulatory agencies worldwide. WRIB was once again a 5-day, weeklong event – A

Aim: Coproporphyrin-I (CP-I) and coproporphyrin-III (CP-III) in plasma and urine have been proposed as biomarkers for assessing drug–drug interactions involving hepatic drug transporters such as organic anion-transporting peptides (OATP), 1B1 and 1B3. Materials & methods: Plasma and urine extracts were analyzed for CP-I/CP-III using a TripleTOF API6600 mass spectrometer. Results: Previously unreported, CP-I/CP-III doubly charged

Aim: To establish a method to simultaneously measure uric acid (UA) and creatinine (Cr) in human saliva. Materials & methods: By using HPLC–MS/MS, we developed and validated a fast, sensitive and accurate method to simultaneously determine UA and Cr in human saliva. The determination range for Cr and UA is of 10–5000 ng/ml with the

Aim: Objective of the current work was to develop a ‘green chemistry’ compliant selective and sensitive supercritical fluid chromatography–tandem mass spectrometry method for simultaneous estimation of risperidone (RIS) and its chiral metabolites in rat plasma. Methodology & results: Agilent 1260 Infinity analytical supercritical fluid chromatography system resolved RIS and its chiral metabolites within runtime of

The 8th Japan Bioanalysis Forum symposium, the Tower Hall Funabori, Tokyo, Japan, 8–9 February 2017 The 8th Japan Bioanalysis Forum (JBF) symposium was successfully held between 8 and 9 February 2017 at the Tower Hall Funabori, Tokyo, Japan. In total, 24 speakers from Japan, USA and Europe gave presentations regarding the immunogenicity of biopharmaceuticals, ICH

Aim: The incurred sample reanalysis (ISR) helps to assure bioanalysis reliability. The regulatory guidelines recommend the reanalysis of up to 10% of the study samples for this test, but not all reanalyses are necessary to evaluate the test result. Materials & methods: We have optimized ISR sample size calculation to eliminate negligible reanalyses. Results: Adjusted

Aim: Assessment of active drug exposure of biologics may be crucial for drug development. Typically, ligand-binding assay methods are used to provide free/active drug concentrations. To what extent hybrid LC–MS/MS procedures enable correct ‘active’ drug quantification is currently under consideration. Experimental & results: The relevance of appropriate extraction condition was evaluated by a hybrid target