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Basic Considerations for Data Pooling Strategy in Multi-Regional Clinical Trials (MRCTs).
Ther Innov Regul Sci
January 2025
Department of Biostatistics, School of Public Health, Peking University, Beijing, China.
The National Medical Products Administration of China has been implementing ICH E17, which describes the general principles for planning and designing of multi-regional clinical trials (MRCTs), yet there are several ambiguities in the execution and conduct remains in China or East Asia. In specific, pooling strategy, effect modifiers (EMs), statistical analysis, sample size allocation and their impact in alignment with global trial remains a challenge. In this paper, we explore on the criteria mentioned above under the context of China.
View Article and Find Full Text PDFThe transgenic MutaMouse hepatocyte mutation assay in vitro: Mutagenicity and mutation spectra of six substances with different mutagenic mechanisms.
Mutat Res Genet Toxicol Environ Mutagen
January 2025
Free University of Berlin, Institute of Pharmacy, Pharmacology and Toxicology, Berlin, Germany; BASF SE, Experimental Toxicology and Ecology, Ludwigshafen am Rhein, Germany.
Mutagenicity testing is a component of the hazard assessment of industrial chemicals, biocides, and pesticides. Mutations induced by test substances can be detected by in vitro and in vivo methods that have been adopted as OECD Test Guidelines. One of these in vivo methods is the Transgenic Rodent Assay (TGRA), OECD test guideline no.
View Article and Find Full Text PDFGRINA alleviates hepatic ischemia‒reperfusion injury-induced apoptosis and ER-phagy by enhancing HRD1-mediated ATF6 ubiquitination.
J Hepatol
January 2025
Department of Minimal Invasive Hepatic Surgery, The First Affiliated Hospital of Harbin Medical University, Harbin, China; Key Laboratory of Hepatosplenic Surgery, Ministry of Education, The First Affiliated Hospital of Harbin Medical University, Harbin, China; Lead contact. Electronic address:
Background & Aims: Hepatic ischemia‒reperfusion injury (HIRI) is a critical complication of liver surgery and transplantation that contributes significantly to severe organ failure. GRINA, a calcium-regulating endoplasmic reticulum (ER) protein, plays an essential role in controlling the unfolded protein response; however, its role in HIRI remains unclear. The aim of this study was to investigate the function of GRINA in HIRI and explore its potential as a therapeutic target.
View Article and Find Full Text PDFIn vitro regeneration and optimization of physical and chemical mutagenesis protocol in tuberose ( (Medik.) Thiede & Govaerts) cv. 'Arka Vaibhav'.
Int J Radiat Biol
January 2025
ICAR-Indian Institute of Horticultural Research, Bengaluru, India.
Purpose: Tuberose ( [Medik.]) is a vegetatively propagated commercial flower crop with limited genetic variability. Crossing barriers prevailing in tuberose necessitates modern breeding techniques like in vitro mutagenesis to generate variability.
View Article and Find Full Text PDFTransient right bundle branch block (RBBB) and S1Q3T3 in a transit passenger due to acute pulmonary embolism- a case report.
Oxf Med Case Reports
January 2025
Emergency Medicine, Hamad General Hospital, Al Rayyan Road, P.O. Box 3050, Doha, Qatar.
Intermittent or transient right bundle branch block (RBBB) can occur in various clinical situations but is rarely described in acute pulmonary embolism. We present a unique case involving a 57-year-old male who experienced a syncopal episode during transit. He displayed signs of a transient right bundle branch block (RBBB) and S1Q3T3 on the initial EMS ECG, which reverted to normal ECG later.
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