The Pre-Implantation Embryo Induces Uterine Inflammatory Reaction in Mice
In: Reproductive sciences: RS : the official journal of the Society for Reproductive Investigation, Volume 28, Issue 1, p. 60-68
ISSN: 1933-7205
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In: Reproductive sciences: RS : the official journal of the Society for Reproductive Investigation, Volume 28, Issue 1, p. 60-68
ISSN: 1933-7205
In: Materials and design, Volume 93, p. 261-270
ISSN: 1873-4197
In: Environmental science and pollution research: ESPR, Volume 20, Issue 10, p. 7071-7079
ISSN: 1614-7499
BACKGROUND: Pertuzumab is a humanized monoclonal antibody for the treatment of breast cancer. HLX11 is a biosimilar of pertuzumab developed by Shanghai Henlius Biotech, Inc. We conducted a bioequivalence study for HLX11 and pertuzumab (United States [US]-, European Union [EU]-, and China [CN]-approved products). OBJECTIVES: This study compared the biosimilarity in pharmacokinetics (PK), safety, and immunogenicity between HLX11 and reference pertuzumab (approved in the US, the EU, and CN) in healthy Chinese male participants after a single infusion and further characterized the PK profile of HLX11. METHODS: Eligible individuals were randomized 1:1:1:1 to receive a single dose of 420 mg HLX11, US-, EU-, or CN-pertuzumab via intravenous infusion over 60 min. The primary endpoints were maximum serum drug concentration (C(max)), area under the serum concentration–time curve (AUC) from time 0 to time of the last quantifiable concentration (AUC(0–t)), and AUC from time 0 to infinity (AUC(0–∞)). PK bioequivalence was established if the 90% confidence intervals (CIs) of the geometric mean ratios of the primary endpoints were between 80.0 and 125.0%. Secondary endpoints included other PK parameters, safety, and immunogenicity. RESULTS: A total of 160 participants were enrolled and randomly assigned to each group (n = 40 per group). The 90% CIs of the geometric mean ratios of the primary endpoints were all within the prespecified equivalence margins (HLX11 vs. pertuzumab [US-, EU-, CN-approved products]: C(max) 97.03–115.06%, 91.39–109.80%, 94.53–110.65%; AUC(0–t) 87.65–99.68%, 87.07–100.79%, 86.29–101.09%; AUC(0–∞) 87.66–99.90%, 87.54–101.05%, 89.23–103.20%). The incidence of adverse drug reactions was comparable across the four groups. The presence of anti-drug antibodies or neutralizing antibodies had no obvious effect on PK. CONCLUSION: The PK, safety, and immunogenicity of HLX11 were highly similar to those of reference pertuzumab (US-, EU-, CN-approved products). The established bioequivalence supports further ...
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In: Journal of risk analysis and crisis response, Volume 6, Issue 4, p. 165
ISSN: 2210-8505
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In: ENVPOL-D-22-07872
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In: AGEE37820
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In: Ecotoxicology and environmental safety: EES ; official journal of the International Society of Ecotoxicology and Environmental safety, Volume 279, p. 116474
ISSN: 1090-2414
To understand the heavy metal pollution in agricultural soils along the East River basin and assess the pollution related health effect to local residents, interviews and archived data were obtained to identify the study sites affected by polluted tailing. Soil samples were collected and tested for heavy metal content and the Comprehensive Pollution Index (CPI). The degree of pollution of agricultural soils in the area was assessed using GIS-based Spatial distribution map of heavy metals and the trend of soil heavy metal risk. Two villages (Matian and Zhudui) near the East River were included in this study for health effect assessment. A total of 193 residents aged 15 or above from each village were tested for the present status of chronic diseases. Convenient sampling method was used to collect blood samples from 78 residents for heavy metal concentration. The contents of Pb, Cd, As, Zn, and Cu in the agricultural soils were all over the standards with a moderate to severe CPI. Among these metals, Cd was the highest followed by Pb, and Cu was the lowest. The contents of Pb, Cd, As, and Zn tend to be higher in soils closer to the river. The prevalence of chronic diseases was over 30%, which is significantly higher than the report from the national central region (23.15%). The average blood lead level (BLL) among children under 14 years is 7.42 μg/dL. Although the adults in Matian village had a significantly higher BLL (χ(2) = 8.70, p = 0.03) as compared to Zhudui village, there was no significant difference for the prevalence of chronic diseases between the two villages (χ(2) = 3.23, p = 0.09). The mean BLL of children and the proportion of children with BLL ≥ 10 µg/dL in this study are equivalent to the national average. The higher BLL concentration and prevalence of chronic diseases in adults might be due to their long-term exposure to heavy metal contamination environment and higher background level of heavy metals. Findings from this study will form the baseline information for local government to the ...
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In: Bulletin of the World Health Organization: the international journal of public health = Bulletin de l'Organisation Mondiale de la Santé, Volume 91, Issue 5, p. 368-376
ISSN: 1564-0604
In: Bulletin of the World Health Organization: the international journal of public health, Volume 91, Issue 5
ISSN: 0042-9686, 0366-4996, 0510-8659
In: BIOACTMAT-D-23-00731
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In: Environmental science and pollution research: ESPR, Volume 20, Issue 10, p. 7009-7026
ISSN: 1614-7499
In: STOTEN-D-22-04657
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