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Bioequivalence of cefalexin in healthy Chinese subjects

Lv X, Zhong G, Yao H, Wu J, Ye S

Int J Clin Pharmacol Ther, 2021 Nov;59(11):725-733.
PMID: 34448694 DOI: 10.5414/CP203986

OBJECTIVE: An earlier three-way crossover study evaluating bioequivalence of 3 cefalexin formulations (capsule for reference, capsule and tablet for test) in healthy subjects in Malaysia showed that the intra-individual coefficients of variation were 9.25% for AUC0-t, 9.54% for AUC0-∞, and 13.90% for Cmax. It is preliminarily stated that cefalexin is not a high-variation product. The here-presented clinical study in China was carried out to analyze the pharmacokinetic properties of two preparations in fasting and postprandial condition to assess the bioequivalence of the test preparation and reference preparation when administered on a fasting and postprandial basis in healthy Chinese subjects and to observe the safety of the test preparation and reference preparation in healthy Chinese subjects.
MATERIALS AND METHODS: In this trial, a total of 56 eligible subjects were randomly assigned to the fasting group and the postprandial group. The two groups were given 250 mg of the test and reference preparation, respectively. Liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) was applied to determine the plasma concentration of cefalexin. PhoenixWinNonlin software (V7.0) was used to calculate the pharmacokinetic parameters of cefalexin using the non-compartmental model (NCA), and the bioequivalence and safety results were calculated by SAS (V9.4) software.
RESULTS: The main pharmacokinetic parameters of the test and reference preparations were as follows, the fasting group: Cmax 12.59 ± 2.65 μg/mL, 12.72 ± 2.28 μg/mL; AUC0-8h 20.43 ± 3.47 h×μg/mL, 20.66 ± 3.38 h×μg/mL; AUC0-∞ 20.77 ± 3.53 h×μg/mL, 21.02 ± 3.45 h×μg/mL; the postprandial group: Cmax 5.25 ± 0.94 μg/mL, 5.23 ± 0.80 μg/mL; AUC0-10h 16.92 ± 2.03 h×μg/mL, 17.09 ± 2.31 h×μg/mL; AUC0-∞ 17.33 ± 2.09 h×μg/mL, 17.67 ± 2.45 h×μg/mL.
CONCLUSION: The 90% confidence intervals of geometric mean ratios of test preparation and reference preparation were calculated, and the 90% confidence intervals of geometric mean ratios of Cmax, AUC0-10h, and AUC0-∞ were within the 80.00% ~ 125.00% range in both groups. Both Cmax and AUC met the pre-determined criteria for assuming bioequivalence. The test and reference products were bioequivalent after administration under fasting as well as under fed conditions in healthy Chinese subjects. This study may suggest that successful generic versions of cefalexin not only guarantee the market supply of such drugs but can also improve the safety and effectiveness and quality controllability of cefalexin through a new process and a new drug composition ratio.
The effect of methyltestosterone (MT) on sex differentiation and growth in juvenile yellow perch (Perca flavescens)

Othman R, Ron XJ, Yao H, O'Bryant P, Rapp D, Pei JC, et al.

Fish Physiol Biochem, 2022 Feb;48(1):161-171.
PMID: 35039993 DOI: 10.1007/s10695-021-01038-0

A study was conducted to evaluate the gonad differentiation of juvenile yellow perch (YP, Perca flavencens) and determine the latest labile period related to hormone treatment. Juvenile fish were subjected to two dietary concentrations of methyltestosterone (MT; 20 and 50 mg/kg feed) for 60 days in three (3) age groups of 38-, 46-, and 67-days post-hatching (dph), where control group were fed with standard commercial feed. Following a 10-month on-growing period, sex phenotypes were determined by gross and histological gonad morphology. Results showed the juvenile YP responded to the exogenous hormone when it was applied at 38 dph for both 20 and 50 mg/kg feed resulting in 100% males. At 46 dph, only 50 mg/kg feed resulted in 100% males. Both MT-treated at 38 and 46 dph significantly differed (P
Fulltext Phytochemicals from fern species: potential for medicine applications

Cao H, Chai TT, Wang X, Morais-Braga MFB, Yang JH, Wong FC, et al.

Phytochem Rev, 2017;16(3):379-440.
PMID: 32214919 DOI: 10.1007/s11101-016-9488-7

Ferns are an important phytogenetic bridge between lower and higher plants. Historically they have been used in many ways by humans, including as ornamental plants, domestic utensils, foods, and in handicrafts. In addition, they have found uses as medicinal herbs. Ferns produce a wide array of secondary metabolites endowed with different bioactivities that could potentially be useful in the treatment of many diseases. However, there is currently relatively little information in the literature on the phytochemicals present in ferns and their pharmacological applications, and the most recent review of the literature on the occurrence, chemotaxonomy and physiological activity of fern secondary metabolites was published over 20 years ago, by Soeder (Bot Rev 51:442-536, 1985). Here, we provide an updated review of this field, covering recent findings concerning the bioactive phytochemicals and pharmacology of fern species.
Research on red tide short-time prediction using GRU network model based on multi-feature Factors--A case in Xiamen sea area

Xiao S, Jian-Feng L, Fang-Fang WAN, Xuan YU, Xiaoxiao S, Lu-Yao HAN, et al.

Mar Environ Res, 2022 Dec;182:105727.
PMID: 36334558 DOI: 10.1016/j.marenvres.2022.105727

Red tide caused severe impacts on marine fisheries, ecology, economy and human life safety. The formation mechanism of the red tide is rather complicated; thus, red tide prediction and forecasting have long been a research hotspot around the globe. This study collected ocean monitoring data before and after the occurrence of red tides in Xiamen sea area from 2009 to 2017. The Pearson correlation coefficient method was used to obtain the associated factors of red tide occurrence, including water temperature, saturated dissolved oxygen, dissolved oxygen, chlorophyll-aand potential of hydrogen. Then, we built a short-time red tide prediction model based on the combination of multiple feature factors. chlorophyll-a, dissolved oxygen, saturated dissolved oxygen, potential of hydrogen, water temperature, salinity, turbidity, wind speed, wind direction and Air pressure were used as the input variables, building a short-time prediction model based on the combination of multiple feature factors to forecast red tide in the next 6 h by using the monitoring data. The accuracy of different forecast models with different feature combinations was compared. Results show that the distinguishing factors which have the most significant influence on red tide prediction in Xiamen are chlorophyll-a, dissolved oxygen, saturated dissolved oxygen, potential of hydrogen, and water temperature. the convergence speed of the Gated Recurrence Unit (GRU) prediction model based on the main feature factor proposed in this paper was faster and obtained the expected result, and the accuracy rates of the buoys are above 92%. The research shows the feasibility to use GRU network model to predict the occurrence of red tide with multi-feature factors as input parameters. the paper provides an effective method for the red tide early warning in Xiamen sea area.
International guideline on natural orifice specimen extraction surgery (NOSES) for colorectal cancer (2025 version)

Liu Z, Wang Z, Yang L, Ma Z, Wang S, Zhou H, et al.

Eur J Surg Oncol, 2026 Nov;52(11):112105.
PMID: 42731257 DOI: 10.1016/j.ejso.2026.112105

PURPOSE: Natural orifice specimen extraction surgery (NOSES) has emerged as a minimally invasive technique in colorectal cancer treatment, offering improved postoperative recovery and cosmetic outcomes. Building upon previous editions, this third edition guideline aims to update and refine technical classifications, indications, and procedural standards based on the latest evidence and accumulated clinical experience.
METHODS: This guideline was jointly developed by the Colorectal Cancer Committee of the China Anti-Cancer Association and the International Alliance of NOSES, incorporating recent multicenter data, consensus discussions, and advancements in laparoscopic and robotic techniques. This updated guideline was developed through an expert consensus-based revision process informed by comprehensive literature review and available multicenter clinical evidence, and was finalized after iterative discussion and approval by the guideline steering committee.
RESULTS: This edition provides targeted updates from the previous version, including refined recommendations on preoperative assessment and acknowledgment of robotic assistance. Adjustments to surgical classifications, indications, and procedural descriptions have also been made to enhance clarity and clinical applicability.
CONCLUSION: This updated guideline provides a structured and practical reference for colorectal NOSES procedures, supporting wider adoption and continued surgical advancement.
Global Burden of Elevated LDL-C: Findings From the Global Burden of Disease Study 2023

GBD 2023 LDL Cholesterol Collaborators, Razo C, DeCleene NK, Johnson CO, Stark BA, LeGrand K, et al.

JAMA, 2026 Aug 25;336(8):673-698.
PMID: 42525403 DOI: 10.1001/jama.2026.8628

IMPORTANCE: Elevated low-density lipoprotein cholesterol (LDL-C) is a modifiable risk factor for cardiovascular disease, the leading cause of premature death worldwide. Assessing the LDL-C-related burden is critical for guiding prevention and treatment strategies.
OBJECTIVES: To estimate the global, regional, and national burden of ischemic heart disease and ischemic stroke attributable to elevated LDL-C (relative to 35-54 mg/dL) from 1990 to 2023 and to quantify the contributions of population growth, aging, risk-deleted burden, and exposure changes to burden trends.
DESIGN, SETTING, AND POPULATION: This comparative risk assessment, part of the Global Burden of Disease Study 2023, estimated population-level LDL-C exposure and associated health loss in 204 countries and territories. Mean LDL-C levels were estimated using spatiotemporal gaussian process regression based on 806 studies across 161 countries. Relative risks were derived from meta-analyses of 38 randomized clinical trials. Population-attributable fractions for deaths and disability-adjusted life-years (DALYs) were estimated by age and sex for adults aged 25 years or older from 1990 to 2023, with 95% uncertainty intervals.
EXPOSURE: Population-level LDL-C concentrations.
MAIN OUTCOMES AND MEASURES: Population-attributable fractions, counts, and rates (all ages and age standardized per 100 000) of LDL-C-attributable deaths and DALYs from ischemic heart disease and ischemic stroke, with uncertainty intervals.
RESULTS: In 2023, elevated LDL-C accounted for 3.6 million deaths (95% uncertainty interval, 2.2-5.4 million; 6.0% of global mortality) and 90.7 million DALYs (95% uncertainty interval, 58.9-123.3 million; 3.2% of DALYs). Although global all-ages rates remained stable, age-standardized death and DALY rates decreased by 45.6% and 39.5%, respectively, since 1990. In 2023, age-standardized LDL-C-attributable DALY rates were highest in Eastern Europe and lowest in high-income Asia-Pacific. One-third of the global LDL-C burden occurred in India and China. Population growth and aging drove the increasing burden, with notable regional disparities in LDL-C exposure and risk-deleted DALY rates shifting toward middle-sociodemographic settings.
CONCLUSIONS AND RELEVANCE: Despite declining age-standardized rates, the absolute LDL-C burden has increased since 1990 due to demographic changes and has shifted toward middle-sociodemographic countries. Measurement and surveillance gaps persist. Strengthened prevention, diagnosis, and treatment access strategies are essential to mitigate the health burden of LDL-C.
Fulltext Guidelines for the use and interpretation of assays for monitoring autophagy (4th edition)1

Klionsky DJ, Abdel-Aziz AK, Abdelfatah S, Abdellatif M, Abdoli A, Abel S, et al.

Autophagy, 2021 Jan;17(1):1-382.
PMID: 33634751 DOI: 10.1080/15548627.2020.1797280

In 2008, we published the first set of guidelines for standardizing research in autophagy. Since then, this topic has received increasing attention, and many scientists have entered the field. Our knowledge base and relevant new technologies have also been expanding. Thus, it is important to formulate on a regular basis updated guidelines for monitoring autophagy in different organisms. Despite numerous reviews, there continues to be confusion regarding acceptable methods to evaluate autophagy, especially in multicellular eukaryotes. Here, we present a set of guidelines for investigators to select and interpret methods to examine autophagy and related processes, and for reviewers to provide realistic and reasonable critiques of reports that are focused on these processes. These guidelines are not meant to be a dogmatic set of rules, because the appropriateness of any assay largely depends on the question being asked and the system being used. Moreover, no individual assay is perfect for every situation, calling for the use of multiple techniques to properly monitor autophagy in each experimental setting. Finally, several core components of the autophagy machinery have been implicated in distinct autophagic processes (canonical and noncanonical autophagy), implying that genetic approaches to block autophagy should rely on targeting two or more autophagy-related genes that ideally participate in distinct steps of the pathway. Along similar lines, because multiple proteins involved in autophagy also regulate other cellular pathways including apoptosis, not all of them can be used as a specific marker for bona fide autophagic responses. Here, we critically discuss current methods of assessing autophagy and the information they can, or cannot, provide. Our ultimate goal is to encourage intellectual and technical innovation in the field.