While low-volume sampling technologies offer numerous advantages over venipuncture, implementation in clinical trials poses technical and logistical challenges. Bioanalytical methods were validated for measuring the concentration of crenezumab and etrolizumab in dried blood samples collected using Mitra and Tasso-M20. The data generated demonstrate that the concentrations of crenezumab and etrolizumab in dried blood collected by […]
This study aims to develop and validate an HPLC technique for the determination of fulvestrant and disulfiram in liposomes. Encapsulation of both drugs into liposomes may improve their anticancer potential. Validation was performed following the International Conference on Harmonization guidelines for specificity, linearity, limit of detection, limit of quantification, precision, accuracy and robustness. Method specificity
Despite the existence of good clinical practice guidelines, the way in which they are applied to the bioanalytical laboratory remains unclear. Aspects of patient confidentiality, informed consent and subject withdrawal; addressing unblinding associated with sample analysis, including repeat analysis and incurred sample reanalysis; or the differences in responsibilities between the sponsor and contract research organization
This paper reviews the application of metabolomics in the early diagnosis of osteoporosis in recent years. The authors searched electronic databases for the keywords “metabolomics”, “osteoporosis” and “biomarkers”, then analyzed the relationship between functional markers and osteoporosis using categorical summarization. Lipid metabolism, amino acid metabolism and energy metabolism are closely related to osteoporosis development and
Aims: Measuring the total and free concentrations of hormones is useful, but the technology to do this simultaneously is lacking. Methods: A new method offers the ability to measure these parameters concurrently for testosterone, thyroxine and triiodothyronine. Results: The free concentrations showed significant correlations with patients’ vital statistics. Overall, 67% of correlations for total concentration
Background: Chlorpromazine is the first antipsychotic drug developed and is included in the list of ‘essential drugs’ prepared by the WHO. Therapeutic drug monitoring is an important point for psychotropic drugs because of significant genetic variability in their metabolism and poor compliance of the patients with treatment. Method: We developed a novel GC–MS method using
Aim: An eco-friendly ultra-performance liquid chromatography–tandem mass spectrometry method was developed to study the pharmacokinetics of rivaroxaban and ticagrelor in rat plasma, utilizing moxifloxacin as an internal standard. The food–drug interaction between grapefruit juice and these drugs was also investigated. Methods: Liquid–liquid extraction was used. A nonporous stationary phase Agilent® Poroshell 120EC C18 column was
Investigating the biodistribution of cell and gene therapy products may play an important role in evaluating their safety and pharmacology. As quantitative polymerase chain reaction (qPCR) is often used for these analyses, it is essential to improve the reliability of bioanalysis performed using qPCR. In this report, the authors discuss the use of qPCR in
Volumetric absorption microsampling devices offer minimally invasive and user-friendly collection of capillary blood in volumes as low as 10 μl. Herein we describe the assay validation for determination of the selective estrogen receptor degrader giredestrant (GDC-9545) in dried human whole blood collected using the Mitra® and Tasso-M20 devices. Both LC–MS/MS assays met validation acceptance criteria for the linear range 1–1000 ng/ml giredestrant. Mitra and Tasso-M20 samples were stable for 84 and 28 days at ambient conditions,
Background: Quantitative bioanalysis of antisense oligonucleotides (ASOs) is crucial to study their pharmacokinetic properties. An ultrasensitive bioanalytical method is often desired for quantifying low-concentration ASOs. Results: Effects of microflow LC and sample cleanness on sensitivity improvement of ASOs were evaluated. Sixfold sensitivity improvement of ASO-001 was achieved using microflow LC–MS/MS compared with conventional analytical flow