Correction to: Safety assessment of drinking water sources along Yangtze River using vulnerability and risk analysis
In: Environmental science and pollution research: ESPR, Band 30, Heft 12, S. 35513-35513
ISSN: 1614-7499
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In: Environmental science and pollution research: ESPR, Band 30, Heft 12, S. 35513-35513
ISSN: 1614-7499
In: Environmental science and pollution research: ESPR, Band 29, Heft 18, S. 27294-27310
ISSN: 1614-7499
In: Materials and design, Band 156, S. 407-418
ISSN: 1873-4197
In: Ecotoxicology and environmental safety: EES ; official journal of the International Society of Ecotoxicology and Environmental safety, Band 227, S. 112907
ISSN: 1090-2414
In: Materials and design, Band 97, S. 86-92
ISSN: 1873-4197
In: Materials and design, Band 110, S. 558-570
ISSN: 1873-4197
In: BITE-D-22-00111
SSRN
In: Waste management: international journal of integrated waste management, science and technology, Band 182, S. 186-196
ISSN: 1879-2456
In: Environmental science and pollution research: ESPR, Band 30, Heft 20, S. 57207-57211
ISSN: 1614-7499
In: Ecotoxicology and environmental safety: EES ; official journal of the International Society of Ecotoxicology and Environmental safety, Band 237, S. 113564
ISSN: 1090-2414
In: WM-23-3524
SSRN
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: Materials and design, Band 186, S. 108336
ISSN: 1873-4197
In: Ecotoxicology and environmental safety: EES ; official journal of the International Society of Ecotoxicology and Environmental safety, Band 275, S. 116255
ISSN: 1090-2414
In: SEPPUR-D-22-01057
SSRN