Search results for "Equivalence"

High flow nasal therapy versus noninvasive ventilation as initial ventilatory strategy in COPD exacerbation: a multicenter non-inferiority randomized…

2020

Abstract Background The efficacy and safety of high flow nasal therapy (HFNT) in patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease (AECOPD) are unclear. Our aim was to evaluate the short-term effect of HFNT versus NIV in patients with mild-to-moderate AECOPD, with the hypothesis that HFNT is non-inferior to NIV on CO2 clearance after 2 h of treatment. Methods We performed a multicenter, non-inferiority randomized trial comparing HFNT and noninvasive ventilation (NIV) in nine centers in Italy. Patients were eligible if presented with mild-to-moderate AECOPD (arterial pH 7.25–7.35, PaCO2 ≥ 55 mmHg before ventilator support). Primary endpoint was the mean di…

Noninferiority of Preservative-free Versus BAK-preserved Latanoprost-timolol Fixed Combination Eye Drops in Patients With Open-angle Glaucoma or Ocul…

2019

UNLABELLED: PRéCIS:: Noninferiority of efficacy was demonstrated for a preservative-free latanoprost-timolol fixed combination compared with a BAK-containing formulation at 84 days after treatment in patients with open-angle glaucoma or ocular hypertension. PURPOSE: The purpose of this study was to compare the effect on intraocular pressure and safety of preservative-free latanoprost-timolol fixed combination (T2347) to benzalkonium chloride-preserved latanoprost-timolol fixed combination in patients with open-angle glaucoma or ocular hypertension. METHODS: Phase III, randomized, parallel-group, investigator-masked study in 10 countries. A total of 242 patients aged 18 years or older with o…

The effects of three absorption-modifying critical excipients on the in vivo intestinal absorption of six model compounds in rats and dogs.

2018

Pharmaceutical excipients that may affect gastrointestinal (GI) drug absorption are called critical pharmaceutical excipients, or absorption-modifying excipients (AMEs) if they act by altering the integrity of the intestinal epithelial cell membrane. Some of these excipients increase intestinal permeability, and subsequently the absorption and bioavailability of the drug. This could have implications for both the assessment of bioequivalence and the efficacy of the absorption-enhancing drug delivery system. The absorption-enhancing effects of AMEs with different mechanisms (chitosan, sodium caprate, sodium dodecyl sulfate (SDS)) have previously been evaluated in the rat single-pass intestin…

Validity of five foot and ankle specific electronic patient-reported outcome (ePRO) instruments in patients undergoing elective orthopedic foot or an…

2019

Background: Patient-reported outcomes (PROS) are widely accepted measures for evaluating outcomes of surgical interventions. As patient-reported information is stored in electronic health records, it is essential that there are valid electronic PRO (ePRO) instruments available for clinicians and researchers. The aim of this study was to evaluate the validity of electronic versions of five widely used foot and ankle specific PRO instruments. Methods: Altogether 111 consecutive elective foot/ankle surgery patients were invited face-to-face to participate in this study. Patients completed electronic versions of the Foot and Ankle Ability Measure (FAAM), the Foot and Ankle Outcome Score (FAOS),…

Influence of Inter- and Intra-Batch Variability on the Sample Size Required for Demonstration of Equivalent Microstructure of Semisolid Dosage Forms

2020

Inter- and intra-batch variability of the quality attributes contribute to the uncertainty for demonstrating equivalent microstructure of post-approval changes and generic/hybrids of semisolid topical products. Selecting a representative sample size to describe accurately the in vitro properties of semisolids and to reach enough statistical power to demonstrate similarity between two semisolid topical products is currently challenging. The objective of this work is to establish the number of batches and units per batch to be compared based on different inter-batch and intra-batch variability to demonstrate equivalence in the physical characteristics of the products that ensure a similar mic…

Air gasification of wood chips, wood pellets and grass pellets in a bubbling fluidized bed reactor

2021

Abstract Gasification is an attractive method for biomass-to-energy conversion and fluidized bed design is one of the best options for large scale operation. A bubbling fluidized bed reactor was used to analyze the effects of biomass type, equivalence ratio (ER) and temperature for product gas compositions. Wood chips, wood pellets and grass pellets were gasified between 650 °C and 800 °C temperature. The ER was varied between 0.08 and 0.16. Gasification of grass pellets was difficult at 800 °C due to agglomeration and the gas composition was poor compared to wood. The reactor performances improved over the temperature and 650 °C was not sufficient to achieve a reasonable carbon conversion.…

Symmetry reduction of a model in spherical symmetry for benign tumor

2004

A PDEs system, describing the expansive growth of a benign tumor and the phe- nomenon of encapsulation, is studied via a group analysis approach. A weak equiv- alence classi¯cation is obtained and the original PDEs system is reduced to an ODEs system. Numerical simulations are performed both for ODEs and PDEs, which turn out to be in perfect agreement between each other, showing a realistic enough description of the biological process.

Equivalence Revisited: Polish Perspectives on the Topic

2019

An Analysis of Bilevel Linear Programming Solving Parameters Based on Factoraggregation Approach

2013

We introduce the notion of factoraggregation,which is a special construction of general aggregation operators, and apply it for an analysis of optimal solution parameters for bilevel linear programming problems. The aggregation observes lower level objective functions considering the classes of equivalence generated by an objective function on the upper level. The proposed method is illustrated with numerical and graphical examples.

A choice of bilevel linear programming solving parameters: factoraggregation approach

2013

Our paper deals with the problem of choosing correct parameters for the bilevel linear program- ming solving algorithm proposed by M. Sakawa and I. Nishizaki. We suggest an approach based on fac- toraggregation, which is a specially designed general aggregation operator. The idea of factoraggregation arises from factorization by the equivalence relation generated by the upper level objective function. We prove several important properties of the factorag- gregation result regarding the analysis of param- eters in order to find an optimal solution for the problem. We illustrate the proposed method with some numerical and graphical examples, in particu- lar we consider a modification of the m…