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  • Klein Bryan posted an update 1 day, 6 hours ago

    Trained agility dogs approached a prosocial actor significantly more often than an antisocial actor, while untrained pet dogs showed no preference for either actor. These differences across dogs with different training histories suggest that while dogs may demonstrate preferences for prosocial others in some contexts, their social evaluation abilities are less flexible and less robust compared to those of humans.Different regulatory agencies provide criteria for selecting a reference product for bioequivalence (BE) studies. In most cases, the criteria vary from one regulatory agency to another, and, consequently, the generic companies often have to repeat the BE studies comparing the same test product with the reference product purchased from a particular country. In addition to being a cost-intensive exercise, this practice is also unethical. The purpose of this article is to discuss the current policy of major regulatory authorities on the selection of the reference product for pharmaceutical equivalence (PE) and BE studies, the cost implications of such regulatory practices, and to also explore the opportunity to harmonize the reference product selection criteria for reducing repetitive BE studies. The regulatory guidance documents of major jurisdictions are reviewed for similarities and differences in generic product definition, BE study design and conduct, and reference product selection criteria for PE and BE studies. A case study is presented to understand how harmonisation can be achieved and how the economic benefits of this harmonisation cannot be underestimated. Harmonisation in reference product selection criteria can pave the way for a common BE study(s) that would be acceptable to the majority of regulatory agencies, and would not only significantly reduce operating costs but would also minimize the exposure of healthy human beings to drugs.Medication use during pregnancy in the absence of pharmacokinetic and safety data is common, particularly for antiretrovirals, as pregnant women are not usually included in clinical trials leading to drug licensure. To date, data are typically generated through opportunistic pregnancy studies performed in the postmarketing setting, leading to a substantial time-lag between initial regulatory approval of a drug and availability of essential pregnancy-specific pharmacokinetic and safety data. During this period, health care providers lack key information on human placental transfer, fetal exposure, optimal maternal dosing in pregnancy, and maternal and fetal drug toxicity, including teratogenicity risk. We discuss new approaches that could facilitate the acquisition of these critical data earlier in the drug development process, aiding clinicians and patients in making informed decisions on drug selection and dosing during pregnancy. An integrated approach utilizing multiple novel methodologies (in vitro, ex vivo, in silico and in vivo) is needed to accelerate the availability of pharmacology data in pregnancy and lactation.

    Solitary pulmonary metastasis from esophageal basaloid squamous cell carcinoma (BSCC) components is an extremely rare recurrence of esophageal squamous cell carcinoma (SCC).

    A 68-year-old Japanese woman was found to have a suspected malignant mass, approximately 2 cm in diameter, in her left lower pulmonary lobe, at 66 months after undergoing a curative esophagectomy with three-field lymph node dissection for esophageal SCC with a focal basaloid component. After a CT-guided biopsy, pathological examination indicated a metastasis from esophageal BSCC components. She underwent a thoracoscopic partial resection of the left lower pulmonary lobe for the solitary pulmonary metastasis. The pathohistology of the resected specimen led to diagnosis of metastatic esophageal BSCC, which showed immunohistochemical findings similar to those of the primary esophageal carcinoma. The patient received two courses of adjuvant chemotherapy (5-fluorouracil, docetaxel plus nedaplatin) and recovered to resume a normal life with maintenance therapy. However, multiple lung and brain metastases were diagnosed at 2 years after the pulmonary metastasectomy. She survived 5 years and 6 months after the pulmonary metastasectomy, but died at 10 years and 6 months after her initial esophagectomy.

    This was a rare surgical resected case of solitary pulmonary metastasis from esophageal BSCC components.

    This was a rare surgical resected case of solitary pulmonary metastasis from esophageal BSCC components.Pre-exposure prophylaxis (PrEP), a highly effective HIV prevention strategy, is currently underutilized by several at-risk groups, including both persons who inject drugs and those who use drugs via other routes. Stimulant use is associated with increased HIV risk due to both sexual and injection risk behaviors. In this study, we examined PrEP awareness and acceptability in persons with biologically confirmed HIV-negative status who use stimulant drugs. We also examined HIV risk behaviors to identify how many participants met behavioral eligibility for PrEP. The sample of 352 participants was 46% female, 87% African American, and 45.69 years old on average. Over half the sample (n = 213) met criteria for PrEP candidacy, but less than 20% had heard of PrEP. Ratings for willingness to take PrEP were high. Relacorilant molecular weight PrEP candidates reported more frequent and problematic stimulant use relative to non-candidates. Our results show that persons who use stimulants are a high-risk population that could benefit significantly from PrEP. Efforts to increase PrEP awareness among high-risk populations are critical for facilitating PrEP implementation and ensuring effective HIV prevention within these communities.Thromboelastography (TEG) is commonly used to predict coagulation state in patients with active bleeding. However, the correlation between TEG parameters and conventional tests in patients with cerebrovascular disease (CVD) remains unexplored. Here, we assessed the TEG values and their correlation with conventional tests in patients with acute cerebral infarction. Eighty-eight patients with acute cerebral infarction were enrolled from the Department of Neurology of Suzhou Medical School. Thirty healthy controls were enrolled from the preventive care department in the same hospital who were taking a physical examination. TEG 5000 thromboelastogram system was used to obtain TEG parameters. The automatic blood coagulation analyzer was used to measure the activated partial thromboplastin time (APTT), prothrombin time (PT), D-Dimer (DD) and fibrinogen (FIB) and platelet function. Among five TEG parameters, the R and K value decreased while MA value, alpha angle and CI value increased in patient group when compared with the healthy controls.

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