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| http://dx.doi.org/10.1111/jch.12149 | DOI Listing |
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Enhancing reliability of embryo-fetal developmental toxicity studies: A proposed design of replicate studies.
Regul Toxicol Pharmacol
January 2025
Independent Teratologist, Philadelphia, PA, USA. Electronic address:
Background: This report addresses the reliability of results from rat Embryo-Fetal Developmental Toxicity (EFDT) studies. Recent literature discusses the roles of reproducibility, replicability, and other influences on scientific reliability. Reproducibility is a re-analysis of the original data, while replicability addresses the same question with a separate study of some type.
View Article and Find Full Text PDFConcordance Between Pharmaceuticals and Medical Devices Agency Review and Ministry of Health, Labour and Welfare Decision Among New Drug Applications in Japan.
Clin Pharmacol Ther
February 2025
Clinical and Translational Research Center, Niigata University Medical and Dental Hospital, Niigata, Japan.
New drug applications (NDAs) in Japan are reviewed by the Pharmaceuticals and Medical Devices Agency (PMDA). Those that pass the review are subsequently subject to deliberation by the Ministry of Health, Labour and Welfare Pharmaceutical Affairs and Food Sanitation Councils (MHLW-PAFSC), and the MHLW legislatively grants approval based on its positive opinions. However, little is known regarding the relationship between the PMDA review and the MHLW decision.
View Article and Find Full Text PDFLong-term stability of sufentanil quantified by UPLC-MS-MS in human plasma frozen for 11 years at -20°C.
J Anal Toxicol
January 2025
Department of Anaesthesiology, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nürnberg (FAU), Krankenhausstr 12, Erlangen 91054, Germany.
The long-term stability of drug concentrations in human plasma samples, when stored under normal laboratory conditions over several years, is important for research purposes and clinical re-evaluation, and forensic toxicology. Fifty human plasma samples from a former clinical trial were re-analyzed after storage at -20°C for 11 years. Plasma samples were extracted using solid-phase extraction.
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Res Synth Methods
November 2024
Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.
In sparse data meta-analyses (with few trials or zero events), conventional methods may distort results. Although better-performing one-stage methods have become available in recent years, their implementation remains limited in practice. This study examines the impact of using conventional methods compared to one-stage models by re-analysing meta-analyses from the Cochrane Database of Systematic Reviews in scenarios with zero event trials and few trials.
View Article and Find Full Text PDFThe impact of biological sex in peripheral nerve blockade: A prospective pharmacodynamic, pharmacokinetic and morphometric study in volunteers.
PLoS One
January 2024
Department of Clinical Pharmacology, Medical University Vienna, Vienna, Austria.
Study Objective: The impact of biological sex in peripheral regional anaesthesia is largely unknown. We therefore designed a prospective study in volunteers to investigate the impact of biological sex on pharmacodynamic, pharmacokinetic and morphometric characteristics for peripheral nerve blockade.
Methods: The initial study plan was powered to include 90 volunteers to find a difference of 35 min in duration of sensory block (primary outcome variable) with 80% power and alpha error at 5%.
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