-
Plants (Basel, Switzerland) Dec 2023Climate change is one of the most prominent factors influencing the spatial distribution of plants in China, including gymnosperms. Climatic factors influence gymnosperm...
Distribution Patterns of Gymnosperm Species along Elevations on the Qinghai-Tibet Plateau: Effects of Climatic Seasonality, Energy-Water, and Physical Tolerance Variables.
Climate change is one of the most prominent factors influencing the spatial distribution of plants in China, including gymnosperms. Climatic factors influence gymnosperm distribution along elevational gradients on the Qinghai-Xizang (Tibet) Plateau (QTP), and understanding how species adapt to these factors is important for identifying the impacts of global climate change. For the first time, we examined the county-level distribution of gymnosperm species on QTP using data from field surveys, published works, monographs, and internet sources. We used simulated distribution data of gymnosperms (N = 79) along the elevational gradients to investigate the overall impact of environmental variables in explaining the richness pattern of gymnosperms. Eighteen environmental variables were classified into three key variable sets (climatic seasonality, energy-water, and physical tolerance). We employed principal component analysis and generalized linear models to assess the impact of climatic variables on the gymnosperm's richness pattern. Gymnosperm species are unevenly distributed across the plateau and decline gradually from the southeast to the northwest. The altitudinal gradients have a unimodal relationship with the richness of gymnosperms, with the maximum species richness at an elevation of 3200 m. The joint effects of physical tolerance and energy-water predictors have explained the highest diversity of gymnosperms at mid-elevation. Because the richness peak correlates significantly with the wettest month's precipitation and moisture index, this confirms the significance of moisture on gymnosperm distributions due to increased precipitation during the wet season. Furthermore, our results provide evidence that climatic seasonality factors are involved in the decline of gymnosperm richness at high elevations. A total of 37% of gymnosperm species on QTP are listed as vulnerable, nearly threatened, or endangered, with elevations ranging from 600 m to 5300 m. As a result, we conclude that gymnosperms are at high risk of extinction because of the current climate fluctuations caused by global climate change. Our research offers fundamental data for the study and protection of gymnosperm species along the steepest elevation gradients.
PubMed: 38068701
DOI: 10.3390/plants12234066 -
Heliyon Nov 2023The synthesis, characterization, optimization and oxidation stability improvement of biodiesel from the seed oil of using a novel nano-heterogeneous bio-catalyst...
The synthesis, characterization, optimization and oxidation stability improvement of biodiesel from the seed oil of using a novel nano-heterogeneous bio-catalyst derived from the seed coat (CASC) is reported. The heterogeneous catalyst was produced by calcination and activation at 400 °C, 600 °C and 800 °C using acetic acid. The catalyst was characterized using scanning electron monograph (SEM), Fourier transform infrared (FTIR), and x-ray diffraction (XRD). The seed oil was extracted using mechanical press milling and the biodiesel produced were characterized using AOAC 2019 edition and ASTM D-6151, Fourier transform infrared (FTIR) and gas chromatography (GC) methods. The results indicated that calcined seed coat contains nano-particles and alkaline elements (75 % graphite). The calcination process improved the size reduction and structural arrangement of the particles. The 600 °C calcination temperature had the highest biodiesel yield of 88 % at 3.0 wt % catalyst concentration, 12:1 M ratio of alcohol to oil and 500 rpm. The reusability of catalyst indicated 71.50 % after fifth (5th) cycle. After 28 days storage duration in the presence of the natural, renewable and eco-friendly antioxidant (1 % turmeric), the oxidation instability of the produced biodiesel was reduced by 50 %. The quality of the biodiesel indicates agreement with standards and literature as well as high potential for effective application in diesel engine.
PubMed: 38034711
DOI: 10.1016/j.heliyon.2023.e22006 -
Archives of Razi Institute Jun 2023Validation is a Good Manufacturing Practice principle that proves any procedure, process, method, equipment, material, activity, or system actually leads to the expected...
Validation is a Good Manufacturing Practice principle that proves any procedure, process, method, equipment, material, activity, or system actually leads to the expected results. This study validates the method for the determination of free formaldehyde in biological products (including the diphtheria-tetanus vaccine and tetanus toxoid antigen). The operating procedure of this method is based on pharmacopoeial monographs. It also does not require full validation, although its suitability under the actual condition of use should be verified. Performance characterizations, such as accuracy, intra-precision (repeatability), intermediate precision (inter-precision), linearity, range, and the limit of quantitation, were investigated and calculated. Accuracy and precision were studied at different concentration levels by spiking known amounts of formaldehyde in real samples. The accuracy and precision results were expressed as the recovery and the relative standard deviation (RSD), respectively. Precision was expressed as intra-precision (repeatability) and inter-precision. Intra-precision or repeatability was performed by one operator in one day by adding three levels of concentration to the products. The inter-precision was conducted by one operator in three individual days within the same laboratory at three concentration levels. Range and linearity were assessed by investigating the correlation coefficient of the regression line between different concentrations of formaldehyde and their response. The acceptance criteria and limits were defined for these validation parameters in these biological products. The RSD for intra-day and inter-day precision studies was less than 5% in a medium concentration of linear range. At this concentration level, accuracy was 90%-110%. The method's linearity ranged between 0.0000039%-0.01% w/v of formaldehyde with a correlation coefficient of 0.9999. The results exhibited sufficient linearity, accuracy, precision, and range. Therefore, this method can be used successfully to determine free formaldehyde for biological products.
Topics: Animals; Diphtheria-Tetanus Vaccine; Tetanus Toxoid; Formaldehyde
PubMed: 38028856
DOI: 10.22092/ARI.2023.358602.2484 -
Environmental Health Perspectives Nov 2023There is a long tradition in environmental health of using frameworks for evidence synthesis, such as those of the U.S. Environmental Protection Agency for its...
BACKGROUND
There is a long tradition in environmental health of using frameworks for evidence synthesis, such as those of the U.S. Environmental Protection Agency for its Integrated Science Assessments and the International Agency for Research on Cancer Monographs. The framework, Grading of Recommendations Assessment, Development, and Evaluation (GRADE), was developed for evidence synthesis in clinical medicine. The U.S. Office of Health Assessment and Translation (OHAT) elaborated an approach for evidence synthesis in environmental health building on GRADE.
METHODS
We applied a modified OHAT approach and a broader "narrative" assessment to assess the level of confidence in a large systematic review on traffic-related air pollution and health outcomes.
DISCUSSION
We discuss several challenges with the OHAT approach and its implementation and suggest improvements for synthesizing evidence from observational studies in environmental health. We consider the determination of confidence using a formal rating scheme of up- and downgrading of certain factors, the treatment of every factor as equally important, and the lower initial confidence rating of observational studies to be fundamental issues in the OHAT approach. We argue that some observational studies can offer high-confidence evidence in environmental health. We note that heterogeneity in magnitude of effect estimates should generally not weaken the confidence in the evidence, and consistency of associations across study designs, populations, and exposure assessment methods may strengthen confidence in the evidence. We mention that publication bias should be explored beyond statistical methods and is likely limited when large and collaborative studies comprise most of the evidence and when accrued over several decades. We propose to identify possible key biases, their most likely direction, and their potential impacts on the results. We think that the OHAT approach and other GRADE-type frameworks require substantial modification to align better with features of environmental health questions and the studies that address them. We emphasize that a broader, "narrative" evidence assessment based on the systematic review may complement a formal GRADE-type evaluation. https://doi.org/10.1289/EHP11532.
Topics: Air Pollution; Environmental Health; Research Design; Observational Studies as Topic
PubMed: 37991444
DOI: 10.1289/EHP11532 -
Saudi Pharmaceutical Journal : SPJ :... Dec 2023India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality and affordable medicines across the globe. Ensuring... (Review)
Review
India has a sparkling pharmaceutical sector that holds a distinguished place by producing and supplying high-quality and affordable medicines across the globe. Ensuring the quality and safety of the marketed medicinal products is one of the most important components of the drug regulatory framework and assessment of the quality of medicines is usually achieved by referring to the public standards of the official Pharmacopoeia. In India, the Indian Pharmacopoeia (IP) is published at regular intervals to fulfill the requirements of the Drugs and Cosmetics Act, 1940 to ensure the quality of medicines being manufactured and/or marketed in India. The present article aims to provide an overview of the history of the IP, its standards-setting process, and the current status of monographs in the 9th edition of the IP 2022. Special focus is placed on the newly added and upgraded general chapters and monographs within the IP 2022. There are a total of 223 general chapters and 3152 drug monographs available under various categories in the IP 2022. This study also highlights a total of 92 new drug monograph additions and 412 monograph revisions in the IP 2022. It is anticipated that the standards laid down in the IP 2022 will play an imperative role in delivering quality medicines to patients within and outside India.
PubMed: 37965488
DOI: 10.1016/j.jsps.2023.101825 -
Journal of Clinical Medicine Oct 2023Intranasal adhesions (synechiae) develop as a result of improper healing of the nasal mucosa. Their incidence ranges from 6.8% to 36% of rhinosurgical procedures. The... (Review)
Review
Intranasal adhesions (synechiae) develop as a result of improper healing of the nasal mucosa. Their incidence ranges from 6.8% to 36% of rhinosurgical procedures. The aim of this study was to review the available publications and monographs dealing with intranasal adhesions-both in the context of formation and risk factors. The study used a review of the literature to determine the articles and studies available in the following medical databases: MEDLINE (National Library of Medicine's), PubMed, and Google Scholar. The following search terms were used: synechiae nasal + synechial nasal + intranasal adhesions + nasal adhesions. The time criterion of available materials was not applied. Available filters in the search engines were used to narrow down the search results. Artificial intelligence was not applied. The review indicated that the risk of intranasal adhesions correlates with the type of surgery, the surgical technique, the dressing materials, and wound care in the postoperative period. Every case requires an individualized approach. Nasal septum separators, (self-)dissolving dressings and (in selected cases) Mitomycin C were investigated thoroughly. Further studies are required which may result in a universal classification system for intranasal adhesions.
PubMed: 37959296
DOI: 10.3390/jcm12216831 -
International Journal of Pharmaceutics:... Dec 2023Although the amount of amorphous content in lactose is low, its impact on the performance of a dry powder inhalation formulation might be high. Many formulators and... (Review)
Review
Although the amount of amorphous content in lactose is low, its impact on the performance of a dry powder inhalation formulation might be high. Many formulators and regulatory agencies believe that the levels of amorphous content should be controlled once there is a relationship with the final product performance. This is however not an easy task. The current paper elaborates on multiple challenges and complexities that are related to the control of the amorphous content in lactose. The definition and quantification methods of amorphous lactose are reviewed, as well as challenges related to thermodynamic instability. Additionally, current monographs and recent position papers considering this parameter are discussed to provide an overview of the regulatory landscape. Development of a control strategy is recommended, provided that the amorphous content at a specific moment in the process has shown to have an impact on the performance of the dry powder inhaler.
PubMed: 37953972
DOI: 10.1016/j.ijpx.2023.100216 -
Environment International Nov 2023A World Health Organization (WHO) and International Labour Organization (ILO) systematic review reported sufficient evidence for higher risk of non-melanoma skin cancer...
Global, regional and national burdens of non-melanoma skin cancer attributable to occupational exposure to solar ultraviolet radiation for 183 countries, 2000-2019: A systematic analysis from the WHO/ILO Joint Estimates of the Work-related Burden of Disease and Injury.
BACKGROUND
A World Health Organization (WHO) and International Labour Organization (ILO) systematic review reported sufficient evidence for higher risk of non-melanoma skin cancer (NMSC) amongst people occupationally exposed to solar ultraviolet radiation (UVR). This article presents WHO/ILO Joint Estimates of global, regional, national and subnational occupational exposures to UVR for 195 countries/areas and the global, regional and national attributable burdens of NMSC for 183 countries, by sex and age group, for the years 2000, 2010 and 2019.
METHODS
We calculated population-attributable fractions (PAFs) from estimates of the population occupationally exposed to UVR and the risk ratio for NMSC from the WHO/ILO systematic review. Occupational exposure to UVR was modelled via proxy of occupation with outdoor work, using 166 million observations from 763 cross-sectional surveys for 96 countries/areas. Attributable NMSC burden was estimated by applying the PAFs to WHO's estimates of the total NMSC burden. Measures of inequality were calculated.
RESULTS
Globally in 2019, 1.6 billion workers (95 % uncertainty range [UR] 1.6-1.6) were occupationally exposed to UVR, or 28.4 % (UR 27.9-28.8) of the working-age population. The PAFs were 29.0 % (UR 24.7-35.0) for NMSC deaths and 30.4 % (UR 29.0-31.7) for disability-adjusted life years (DALYs). Attributable NMSC burdens were 18,960 deaths (UR 18,180-19,740) and 0.5 million DALYs (UR 0.4-0.5). Men and older age groups carried larger burden. Over 2000-2019, attributable deaths and DALYs almost doubled.
CONCLUSIONS
WHO and the ILO estimate that occupational exposure to UVR is common and causes substantial, inequitable and growing attributable burden of NMSC. Governments must protect outdoor workers from hazardous exposure to UVR and attributable NMSC burden and inequalities.
Topics: Male; Humans; Aged; Ultraviolet Rays; Cross-Sectional Studies; Occupational Exposure; Skin Neoplasms; World Health Organization; Cost of Illness; Occupational Diseases
PubMed: 37945424
DOI: 10.1016/j.envint.2023.108226 -
Neurology India 2023
Topics: Humans; Meningioma; Meningeal Neoplasms
PubMed: 37929505
DOI: 10.4103/0028-3886.388046 -
Journal of the Medical Library... Oct 2023To evaluate tertiary drug information databases in terms of scope, consistency of content, and completeness of COVID-19 drug information.
OBJECTIVE
To evaluate tertiary drug information databases in terms of scope, consistency of content, and completeness of COVID-19 drug information.
METHODS
Five electronic drug information databases: Clinical Pharmacology, Lexi-Drugs, AHFS DI (American Hospital Formulary Service Drug Information), eFacts and Comparisons, and Micromedex In-Depth Answers, were evaluated in this cross-sectional evaluation study, with data gathered from October 2021 through February 2022. Two study investigators independently extracted data (parallel extraction) from each resource. Descriptive statistics were primarily used to evaluate scope (i.e., whether the resource addresses use of the medication for treatment or prevention of COVID-19) and completeness of content (i.e., whether full information is provided related to the use of the medication for treatment or prevention of COVID-19) based on a 10-point scale. To analyze consistency among resources for scope, the Fleiss multi-rater kappa was used. To analyze consistency among resources for type of recommendation (i.e., in favor, insufficient evidence, against), a two-way mixed effects intraclass coefficient was calculated.
RESULTS
A total of 46 drug monographs, including 3 vaccination monographs, were evaluated. Use of the agents for treatment of COVID-19 was most frequently addressed in Lexi-Drugs (73.9%), followed by eFacts and Comparisons (71.7%), and Micromedex (54.3%). The highest overall median completeness score was held by AHFS DI followed by Micromedex, and Clinical Pharmacology. There was moderate consistency in terms of scope (kappa 0.490, 95% CI 0.399-0.581, p<0.001) and recommendations (intraclass correlation coefficient 0.518, 95% CI 0.385-0.651, p<0.001).
CONCLUSION
Scope and completeness results varied by resource, with moderate consistency of content among resources.
Topics: United States; Humans; Cross-Sectional Studies; Information Sources; Drug Information Services; COVID-19; Databases, Factual
PubMed: 37928123
DOI: 10.5195/jmla.2023.1662