Carbidopa/levodopa dose elevation and safety concerns in Parkinson's patients: a cross-sectional and cohort design by Michael S Okun, Peter Schmidt, David W Brodell, Nicole T Stanford, Charles E Jacobson

“…When approved by the Food and Drug Administration (FDA) in 1988, a maximum daily dosage limit of 800 mg (eight tablets) of the 25/100 carbidopa/levodopa formulation was introduced. …”
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Comparative, cross-sectional study of the format, content and timing of medication safety letters issued in Canada, the USA and the UK by Jeremy M Grimshaw, Margaret C Watson, Lise M Bjerre, Matthew Hogel, Cody D Black, Simon Parlow, David de Launay, Donald R Mattison

“…Objectives To assess consistency in the format and content, and overlap of subject and timing, of medication safety letters issued by regulatory health authorities to healthcare providers in Canada, the USA and the UK.Design A cross-sectional study comparing medication safety letters issued for the purpose of alerting healthcare providers to newly identified medication problems associated with medications already on the market.Setting Online databases operated by Health Canada, the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency were searched to select medication safety letters issued between 1 January 2010 and 31 December 2014. …”
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Revamping field practicum: insights for future health services management professionals by Fatemeh Mohabati, Marzieh Arefi, Seyed Pouria Hedayati

“…To achieve desirable outcomes through a fundamental revision strategy, it was decided that, in addition to students’ presence in hospitals (including the office of senior hospital managers and the quality improvement and accreditation unit), students should also be present in the deputyships and central units of Zabol University of Medical Sciences (treatment, resource development and management, food and drug administration, and the center for management of medical emergencies). …”
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Metformin and Probiotics Interplay in Amelioration of Ethanol-Induced Oxidative Stress and Inflammatory Response in an In Vitro and In Vivo Model of Hepatic Injury by Farhin Patel, Kirti Parwani, Dhara Patel, Palash Mandal

“…Despite rigorous research, there is still no Food and Drug Administration (FDA) approved therapies for any stage of alcoholic liver disease (ALD). …”
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A post-marketing pharmacovigilance study of triazole antifungals: adverse event data mining and analysis based on the FDA adverse event reporting system database by Yalan Tian, Min Jin, Hong Ning

“…BackgroundTo explore and analyze post-marketing adverse drug event (ADE) signals for voriconazole, posaconazole, and isavuconazole, and to compare the safety differences among the three drugs, aiming to provide insights for rational clinical use.MethodsUsing the Open Vigil 2.1 online tool, extract adverse drug event (ADE) report data for voriconazole, posaconazole, and isavuconazole from the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) database from the time the drugs were marketed up to the third quarter of 2023. …”
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Antibacterial Effect of Sea Buckthorn ( Hippophae rhamnoides L.) Fruit Extract on Radish Seeds Prior to Sprouting by Katarzyna Rajkowska, Emilia Rykała, Agata Czyżowska

“…The efficacy of 15-min seed treatment and 3-h soaking in the extract solution was evaluated in comparison to the treatment with 20,000 mg/L calcium hypochlorite, recommended by the U.S. Food and Drug Administration. The effect of the sea buckthorn fruit extract on radish seed germination capacity and the profile of phenolic compounds in the extract were also determined. …”
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An in-vivo herb-drug interaction study of IME-9 and glimepiride in nicotinamide-STZ-induced diabetic rats by Archana K. Thikekar, Asha B. Thomas, Sohan S. Chitlange

“…Methods: The RP-HPLC technique was devised and validated in accordance with the guidelines set by the US Food and Drug Administration (FDA). PK and PD parameters were computed on both day 1 and 21 in vivo. …”
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Pharmacokinetics and Bioavailability Study of Tubeimoside I in ICR Mice by UPLC-MS/MS by Lianguo Chen, Qinghua Weng, Feifei Li, Jinlai Liu, Xueliang Zhang, Yunfang Zhou

“…A validation of this method was in accordance with the US Food and Drug Administration (FDA) guidelines. The lower limit of quantification (LLOQ) of TBMS-I was 2 ng/mL, and the calibration curve was linearly ranged from 2 to 2000 ng/mL (r2 ≥ 0.995). …”
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Development and Validation of a Bordetella pertussis Whole-Genome Screening Strategy by Ricardo da Silva Antunes, Lorenzo G. Quiambao, Aaron Sutherland, Ferran Soldevila, Sandeep Kumar Dhanda, Sandra K. Armstrong, Timothy J. Brickman, Tod Merkel, Bjoern Peters, Alessandro Sette

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The Effect of Zinc Supplementation on Glycemic, Weight, and Blood Pressure Control in Patients With Type 2 Diabetes Mellitus: A Double‐Blind Randomized Controlled Trial by Mehrab Sayadi, Sara Javadpour Nowbandegani, Fatemeh Balaghi Inalou, Bahman Nazemzadegan, Shirzad Javidi Alsaadi, Mohammadreza Eskandari, Matin Sepehrinia

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Proinflammatory Cytokine IL-6 and JAK-STAT Signaling Pathway in Myeloproliferative Neoplasms by Vladan P. Čokić, Olivera Mitrović-Ajtić, Bojana B. Beleslin-Čokić, Dragana Marković, Marijana Buač, Miloš Diklić, Nada Kraguljac-Kurtović, Svetozar Damjanović, Pavle Milenković, Mirjana Gotić, Puri K. Raj

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Receipt of long-acting injectable antiretroviral therapy among people with HIV in Southern US states: an assessment using electronic health records and claims data by Yiyang Liu, Rebecca J. Fisk-Hoffman, Maitri Patel, Robert L. Cook, Mattia Prosperi

“…Abstract Background In January 2021, the United States (US) Food and Drug Administration (FDA) approved the first long-acting injectable antiretroviral therapy (LAI ART) regimen for the treatment of HIV providing an alternative to daily oral regimens. …”
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Data mining and safety analysis of voriconazole in patients with a hematological malignant tumor based on the FAERS database: differences between children and adults by Hao Li, Hao Li, Manxue Jiang, Manxue Jiang, Xiaona Pan, Lingti Kong, Lingti Kong, Lingti Kong

“…We assessed the adverse drug events (ADEs) of voriconazole in this population based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to improve understanding of the safety of voriconazole.Research design and methodsADE reports for patients with a hematological malignant tumor using voriconazole between the first quarter of 2004 to the first quarter of 2024 were retrieved. …”
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Environmental sustainability profiles assessment of HPLC stability indicating method for quantitation of piracetam and vincamine in pharmaceutical medications by Samya Sh. Alenezi, Ayman A. Gouda, Ragaa El Sheikh, Niaf A. Badahdah, Muneer E Alzuhiri, Ali H. Magrabi, Asim L. Jilani, Ahmed S. Darwish

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Принципы использования рекомбинантных аденоассоциированных вирусов в исследованиях и терапии by Марченко С.А., Ланшаков Д.А.

“…В 2023 г. Food and Drug Administration (FDA – Управление по контролю качества пищевых продуктов и лекарственных средств, США) был одобрен препарат Roctavian для лечения гемофилии A на основе AAV. …”
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Utility of Integrated Analysis of Pharmacogenomics and Pharmacometabolomics in Early Phase Clinical Trial: A Case Study of a New Molecular Entity by Jaeseong Oh, Sojeong Yi, Namyi Gu, Dongseong Shin, Kyung-Sang Yu, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang

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CRISPR screen reveals modifiers of rAAV production including known rAAV infection genes playing an unexpected role in vector production by Emily E. O’Driscoll, Sakshi Arora, Jonathan F. Lang, Beverly L. Davidson, Ophir Shalem

“…Recombinant adeno-associated virus (rAAV) vectors are an effective and well-established tool in the growing gene therapy field, with five U.S. Food and Drug Administration-approved AAV-mediated gene therapies already on the market and numerous more in clinical trials. …”
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Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS by Ganggang Wang, Lin Su, Yanjun Liu, Xiaohan Yang, Yi Li, Qi Mei, Qi Mei, Wen Gao

“…However, further research is required to better define its safety profile.ObjectivesTo determine the cardiovascular toxicity of tisagenlecleucel in children and adolescents.MethodsThe US Food and Drug Administration’s Adverse Event Reporting System was searched to identify cardiovascular adverse events (CVAEs) related to tisagenlecleucel in pediatric patients up to the age of 18 years.ResultsThe median time to onset of tisagenlecleucel-associated CVAEs was shorter than that of tisagenlecleucel-associated non-CVAEs (3 days [interquartile range (IQR) 1, 6] vs. 7 days [IQR 2, 54]). …”
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Haemophagocytic lymphohistiocytosis in patients treated with immune checkpoint inhibitors: analysis of WHO global database of individual case safety reports by Alessandro Ceschi, Roberta Noseda, Raffaela Bertoli, Laura Müller

“…We retrieved the individual case safety reports reporting HLH in association with ipilimumab, nivolumab, pembrolizumab, atezolizumab, avelumab or durvalumab, gathered in the database starting from the ICIs’ approval dates by the US Food and Drug Administration. The main outcome measures were co-suspected drugs, concurrent irAEs, HLH clinical, haematological and coagulation features, concomitant infections, HLH median time to onset and outcome.Results Among 49′883 ICI-related ADRs collated in VigiBase as of September 30th, 2018, HLH was reported in 38 cases of which 34 (90%) mentioned ICIs as the solely suspected drugs. …”
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CAR T-cell detection scoping review: an essential biomarker in critical need of standardization by Naomi Taylor, Nirali N Shah, David P Turicek, Victoria M Giordani, Josquin Moraly

“…Focusing on 21 clinical trials from the USA, featuring a Food and Drug Administration-approved CAR T-cell construct or one of its predecessors, 105 manuscripts were screened and 60 were selected for analysis, based on the inclusion of CAR T-cell expansion and persistence data. …”
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