european approval
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2021 ◽  
Author(s):  
Łukasz Warguła ◽  
Piotr Lijewski ◽  
Mateusz Kukla

Abstract The development and operation of road infrastructure requires machines and equipment driven by low-powered internal combustion engines. The authors of this paper examined five small spark-ignition engines. They used the most popular commercial design on the market, the Lifan GX 390, with a carburettor power system, and another commercial power unit with the most innovative power system, the Honda iGX 390, characterised by an electronically controlled carburettor flap. The remaining three tested constructions are proprietary solutions modernising the design of the Lifan GX 390 engine. The first is the application of an electronic injection and ignition system powered by gasoline, the second and third are systems powered by alternative fuels. Emissions tests were conducted under identical operating conditions on an engine dynamometer coinciding with European Union guidelines (Regulation 2016/1628/EU).The results of the tests showed that innovative solutions in most cases reduced CO,CO2, and HC emissions while increasing NOx compounds.


2019 ◽  
Vol 76 (3) ◽  
pp. 349-361 ◽  
Author(s):  
Shampa Das ◽  
Diansong Zhou ◽  
Wright W. Nichols ◽  
Andy Townsend ◽  
Paul Newell ◽  
...  

Abstract Purpose Ceftazidime–avibactam is a novel β-lactam/β-lactamase inhibitor combination recently approved in Europe and the USA for the treatment of adults with hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP), among other indications. In the phase III REPROVE trial (NCT01808092), ceftazidime–avibactam demonstrated non-inferiority to meropenem for the treatment of patients with nosocomial pneumonia (NP), including VAP. As ceftazidime–avibactam was not studied in patients with NP prior to REPROVE, selecting an appropriate dosage regimen in the “perfect storm” of NP required careful consideration of potential determinants and confounders of response specific to the NP patient population. Methods This review describes the series of preclinical studies and pharmacokinetic/pharmacodynamic (PK/PD) analyses that supported ceftazidime–avibactam dosage selection for patients with NP/VAP (2000/500 mg by 2-h intravenous infusion every 8 h, adjusted for renal function). In parallel, important considerations for antibiotic dosage selection in patients with NP are highlighted, including adequate drug penetration into the lungs, the suitability of murine-derived plasma PK/PD targets, evaluation of MIC distributions against clinical bacterial isolates from patients with NP, and consideration of PK in patients with NP, who are often critically ill. These analyses also supported the European approval of ceftazidime–avibactam for adults with HAP, including VAP, before the completion of REPROVE. Conclusions This work serves as a successful practical example of dosage design for a new antibacterial drug therapy in the indication of NP, including VAP, where previous drug therapies have failed, possibly as a result of evaluation of too few variables, thereby limiting the accuracy of pharmacodynamic predictions.


2016 ◽  
Vol 12 (2) ◽  
pp. e235-e243 ◽  
Author(s):  
Alec Vahanian ◽  
Marina Urena ◽  
Thomas Walther ◽  
Hendrik Treede ◽  
Olaf Wendler ◽  
...  

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