A Score to Predict the Clinical Usefulness of Therapeutic Drug Monitoring: Application to Oral Molecular Targeted Therapies in Cancer
This study evaluates a quantitative approach with a score to predict the clinical usefulness of TDM for oMTTs. We identified key parameters for an oMTT's suitability for TDM from standard TDM recommendations. We gathered oMTT pharmacological data, which covered exposure variability (considering pharmacokinetic (PK) impact of food and proton pump inhibitors), technical intricacy (PK linearity and active metabolites), efficacy (exposure-response relationship), and safety (maximum tolerated dose, and exposure-safety relationship). To assess the validity and the relevance of the score and define relevant thresholds, we evaluat...
Source: Clinical Pharmacology and Therapeutics - February 23, 2024 Category: Drugs & Pharmacology Authors: Arthur G éraud David Combarel Christian Funck-Brentano Quentin Beaulieu No ël Zahr Sophie Broutin Jean-Philippe Spano Christophe Massard Benjamin Besse Paul Gougis Source Type: research

Risk of exposure to aflatoxin M1 through consumption of cow ’s milk among children in Magadu, Morogoro
This study determined AFM1 contamination of cow ’s milk and estimated the health risk of dietary AFM1 through consumption of cow’s milk among children (6 to 36 months) in the Magadu ward of Morogoro region in Tanzania. A total of 165 mother-baby pairs were recruited and interviewed on child feeding practices with a focus on feeding of cow’ s milk in the past 24 h. Alongside the interview, 100 raw cows’ milk samples were collected from subsampled respondent households and were analyzed for AFM1 using enzyme-linked immunosorbent assay (ELISA). The results showed that about 35% of the surveyed children consumed cowâ...
Source: Mycotoxin Research - February 23, 2024 Category: Toxicology Source Type: research

What Electrophysiologists Should Know about Cardiac Implantable Electronic Device Recalls
From 2003-2023, manufacturers recalled 500 cardiac implantable electronic device (CIED) products, including pulse generators, leads, and programmers.1 Manufacturers of CIEDs have a legal responsibility to protect the public health under laws administered by the Food and Drug Administration (FDA)2. A CIED recall is a method of removing or correcting marketed products that violate these laws because the products either are defective or present a risk of death or injury.3 (Source: Heart Rhythm)
Source: Heart Rhythm - February 23, 2024 Category: Cardiology Authors: Robert G. Hauser, Charles D. Swerdlow Source Type: research

Enantioselective polar-organic mode high-performance liquid chromatographic separation of lifitegrast on immobilized polysaccharide stationary phase and its application to pH-dependent chiral interconversion studies
Chirality. 2024 Feb;36(2):e23636. doi: 10.1002/chir.23636.ABSTRACT(S)-Lifitegrast (LFT) is the novel integrin antagonist, approved by the Food and drug administration, to treat signs and symptoms of dry eye disease. Synthesis of racemic LFT, preparative and analytical enantiomer separation, and chiral interconversion studies are lacking in the literature. Hence, in our study, synthesis of LFT racemate, chiral preparative purification procedure of enantiomer, and comprehensive analytical advancements are focused on rapid enantioselective separation and pH-dependent chiral interconversion studies. The synthesis of LFT racema...
Source: Chirality - February 22, 2024 Category: Molecular Biology Authors: Jony Susanna Kandula Veera Venkata Satya Prasanna Kumari Rayala Keyur Parmar Veerabhadra Swamy Ponnapalli Mahendar Gantala Radhakrishnanand P Source Type: research

Sacituzumab govitecan plus platinum-based chemotherapy mediates significant antitumor effects in triple-negative breast, urinary bladder, and small-cell lung carcinomas
Oncotarget. 2024 Feb 22;15:144-158. doi: 10.18632/oncotarget.28559.ABSTRACTSacituzumab govitecan (SG) is an antibody-drug conjugate composed of an anti-Trop-2-directed antibody conjugated with the topoisomerase I inhibitory drug, SN-38, via a proprietary hydrolysable linker. SG has received United States Food and Drug Administration (FDA) approval to treat metastatic triple-negative breast cancer (TNBC), unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and accelerated approval for metastatic urothelial cancer. We investigated...
Source: Oncotarget - February 22, 2024 Category: Cancer & Oncology Authors: Thomas M Cardillo Maria B Zalath Roberto Arrojo Robert M Sharkey Serengulam V Govindan Chien-Hsing Chang David M Goldenberg Source Type: research

Enantioselective polar-organic mode high-performance liquid chromatographic separation of lifitegrast on immobilized polysaccharide stationary phase and its application to pH-dependent chiral interconversion studies
Chirality. 2024 Feb;36(2):e23636. doi: 10.1002/chir.23636.ABSTRACT(S)-Lifitegrast (LFT) is the novel integrin antagonist, approved by the Food and drug administration, to treat signs and symptoms of dry eye disease. Synthesis of racemic LFT, preparative and analytical enantiomer separation, and chiral interconversion studies are lacking in the literature. Hence, in our study, synthesis of LFT racemate, chiral preparative purification procedure of enantiomer, and comprehensive analytical advancements are focused on rapid enantioselective separation and pH-dependent chiral interconversion studies. The synthesis of LFT racema...
Source: Chirality - February 22, 2024 Category: Molecular Biology Authors: Jony Susanna Kandula Veera Venkata Satya Prasanna Kumari Rayala Keyur Parmar Veerabhadra Swamy Ponnapalli Mahendar Gantala Radhakrishnanand P Source Type: research

Sacituzumab govitecan plus platinum-based chemotherapy mediates significant antitumor effects in triple-negative breast, urinary bladder, and small-cell lung carcinomas
Oncotarget. 2024 Feb 22;15:144-158. doi: 10.18632/oncotarget.28559.ABSTRACTSacituzumab govitecan (SG) is an antibody-drug conjugate composed of an anti-Trop-2-directed antibody conjugated with the topoisomerase I inhibitory drug, SN-38, via a proprietary hydrolysable linker. SG has received United States Food and Drug Administration (FDA) approval to treat metastatic triple-negative breast cancer (TNBC), unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and accelerated approval for metastatic urothelial cancer. We investigated...
Source: Oncotarget - February 22, 2024 Category: Cancer & Oncology Authors: Thomas M Cardillo Maria B Zalath Roberto Arrojo Robert M Sharkey Serengulam V Govindan Chien-Hsing Chang David M Goldenberg Source Type: research

Enantioselective polar-organic mode high-performance liquid chromatographic separation of lifitegrast on immobilized polysaccharide stationary phase and its application to pH-dependent chiral interconversion studies
Chirality. 2024 Feb;36(2):e23636. doi: 10.1002/chir.23636.ABSTRACT(S)-Lifitegrast (LFT) is the novel integrin antagonist, approved by the Food and drug administration, to treat signs and symptoms of dry eye disease. Synthesis of racemic LFT, preparative and analytical enantiomer separation, and chiral interconversion studies are lacking in the literature. Hence, in our study, synthesis of LFT racemate, chiral preparative purification procedure of enantiomer, and comprehensive analytical advancements are focused on rapid enantioselective separation and pH-dependent chiral interconversion studies. The synthesis of LFT racema...
Source: Chirality - February 22, 2024 Category: Molecular Biology Authors: Jony Susanna Kandula Veera Venkata Satya Prasanna Kumari Rayala Keyur Parmar Veerabhadra Swamy Ponnapalli Mahendar Gantala Radhakrishnanand P Source Type: research

Sacituzumab govitecan plus platinum-based chemotherapy mediates significant antitumor effects in triple-negative breast, urinary bladder, and small-cell lung carcinomas
Oncotarget. 2024 Feb 22;15:144-158. doi: 10.18632/oncotarget.28559.ABSTRACTSacituzumab govitecan (SG) is an antibody-drug conjugate composed of an anti-Trop-2-directed antibody conjugated with the topoisomerase I inhibitory drug, SN-38, via a proprietary hydrolysable linker. SG has received United States Food and Drug Administration (FDA) approval to treat metastatic triple-negative breast cancer (TNBC), unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and accelerated approval for metastatic urothelial cancer. We investigated...
Source: Oncotarget - February 22, 2024 Category: Cancer & Oncology Authors: Thomas M Cardillo Maria B Zalath Roberto Arrojo Robert M Sharkey Serengulam V Govindan Chien-Hsing Chang David M Goldenberg Source Type: research