The use of medications during lactation is a common practice; however, pharmacological treatments impose serious doubts to both professionals and nursing mothers regarding the safety of drugs used during this period. Most of drugs are excreted in breast milk and there is great variability in the amount of analytes that can be received by the infant. Dilemmas about breastfeeding arise most commonly in relation to postpartum depression. Depression is a major clinical problem during the postpartum period and the vulnerability to onset or recurrence of depressive symptoms increases the possibility of psychotropic drug use during lactation. Selective inhibitors of serotonin reuptake are commonly prescribed for the treatment of depressive disorders, including fluoxetine, sertraline, citalopram, and paroxetine. A validated bioanalytical method using liquid chromatography coupled to mass spectrometry was developed and validated for determination of antidepressants in human milk following protein precipation. The bioanalytical method was successfully applied to assess milk samples from nursing mothers. From found concentrations, infant absolute (4.36-12.26μg/kg/day) and relative dose (0.60-2.90%,) were estimated and low values were obtained indicating safe use during laction. However, other factors such as complemantary feeding and hepatic or renal disorders in the infant should be considered.
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http://dx.doi.org/10.1016/j.jpba.2016.07.047 | DOI Listing |
ACS Sens
January 2025
Department of Chemistry, Wayne State University, 5101 Cass Ave, Detroit, Michigan 48202, United States.
Bioanalytical sensors are adept at quantifying target analytes from complex sample matrices with high sensitivity, but their multiplexing capacity is limited. Conversely, analytical separations afford great multiplexing capacity but typically require analyte labeling to increase sensitivity. Here, we report the development of a separation-based sensor to sensitively quantify unlabeled polysaccharides using particle motion tracking within a microfluidic electrophoresis platform.
View Article and Find Full Text PDFAnal Methods
January 2025
Microelectronic Research & Development Center, School of Mechatronics Engineering and Automation, Shanghai University, Shanghai 200444, China.
An integrated magnetoimpedance (MI) biosensor microfluidic magnetic platform was proposed for the evaluation of the cardiac marker, cardiac troponin I (cTnI). This bioanalyte evaluation platform mainly comprised three external permanent magnets (PMs), one MI element, two peelable SiO film units and a microfluidic chip (MFC). The MI element was made of micro-electro-mechanical system (MEMS)-based multilayered [Ti (6 nm)/FeNi (100 nm)]/Cu (400 nm)/[Ti (6 nm)/FeNi (100 nm)] thin films and designed as meander structures with closed magnetic flux.
View Article and Find Full Text PDFFront Immunol
January 2025
Polpharma Biologics S.A., Gdansk, Poland.
Background: Biosimilar natalizumab (biosim-NTZ) is the first biosimilar monoclonal antibody of reference natalizumab (ref-NTZ) for treatment of relapsing forms of multiple sclerosis (MS). Within the totality of evidence for demonstration of biosimilarity, immunogenicity assessments were performed in healthy subjects and patients with relapsing-remitting MS (RRMS) to confirm a matching immunogenicity profile between biosim-NTZ and ref-NTZ.
Methods: Immunogenicity of biosim-NTZ versus ref-NTZ was evaluated in two pivotal clinical studies.
J Pharmacol Toxicol Methods
December 2024
Department of Immunoassay and Immunochemistry, Center for Drug Safety Evaluation and Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China; State Key Laboratory of Drug Research, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai 201203, China; University of Chinese Academy of Sciences, Beijing 101408, China; Zhongshan Institute for Drug Discovery, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Zhongshan 528400, China. Electronic address:
Background: Antibody-drug conjugates (ADCs) are an emerging class of targeted therapeutics and are receiving growing attention in the pharmaceutical field. Here we aimed to validate two ligand binding assays for the quantitation of GQ1001, an ADC made of Trastuzumab site-specifically conjugated with DM1, in cynomolgus monkey serum, and then apply the validated assays to a nonclinical study.
Methods: The quantitative methods for conjugated GQ1001 and total GQ1001 were validated against regulatory guidance documents on bioanalytical method validation under a Good Laboratory Practice (GLP)-compliant environment.
J Sep Sci
January 2025
Department of Analytical, Bioanalytical Sciences and Miniaturization (LSABM) Chemistry, Biology and Innovation (CBI), UMR CNRS-ESPCI Paris 8231, ESPCI Paris, PSL University, CNRS, Paris, France.
Adduction on protein nucleophile sites by mustard agents can be monitored to assess detection of retrospective exposure to these agents. Cysteine 34 (Cys34) on human serum albumin was selected as the target of choice. This work targets di- and tripeptides adducted on Cys34 by sulfur mustard, sesquimustard, and nitrogen mustards separated in hydrophilic liquid chromatography (HILIC) and Reversed-Phase (RP) mode.
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