scholarly journals Rational Selection, Criticality Assessment, and Tiering of Quality Attributes and Test Methods for Analytical Similarity Evaluation of Biosimilars

2018 ◽  
Vol 20 (4) ◽  
Author(s):  
Kristof Vandekerckhove ◽  
Andreas Seidl ◽  
Hiten Gutka ◽  
Manish Kumar ◽  
Gyöngyi Gratzl ◽  
...  
2014 ◽  
Vol 70 (4) ◽  
Author(s):  
Anil Minhans ◽  
Shamsuddin Shahid ◽  
Ishtiaque Ahmed

Public transport usage in Malaysia is showing a downward trend. Despite major improvements implemented as well as intended for public transport, the bus user satisfaction is constantly on a decline. This study investigated qualitative differences between bus users and operators based on 11 pre-selected quality attributes for an intercity travel in Malaysia with a predominant public transport mode– the Bus. The perceptions were measured via responses on a likert scale to establish differences. Perceptual, socio-economic and trip data were collected using questionnaire from bus users and operators on a pre-selected route-Johor Bahru to Kuala Lumpur (JB-KL). Analyses used statistical tools particularly correlation analyses, step-wise multiple regression analyses, Mann Whitney test methods and Wilcoxon test. Quadrant analyses established relationship between relative importance and satisfaction from quality attributes. Results indicate significant correlation differences in both groups on attributes viz. ‘bus fares’ ‘travel comfort’, ‘travel convenience’, ‘ticket availability’ and the ‘facilities at the bus terminal’. Study revealed significant gaps in the understanding about the composition of bus service-quality by operators. Alternate hypothesis were rejected as bus users and operators reveal significant perception differences on quality attributes–‘bus fares’, ‘travel comfort’ and ‘bus staff behaviour’. The satisfaction levels of four extremely important quality attributes viz. ‘bus fares’, ‘travel comfort’, ‘bus staff behaviour’ and ‘bus user security’ were found low to average. Similarly major deterrents of the bus patronage were appraised. In this endeavour, the research exploited knowledge of perceptions to suggest quality attributes that are necessary to improve public transport ridership and consequently the modal share of public transport in Malaysia.


2001 ◽  
Vol 120 (5) ◽  
pp. A586-A587
Author(s):  
L BEST ◽  
S JO ◽  
V VANZANTEN ◽  
D HALDANE ◽  
V LOO ◽  
...  

1990 ◽  
Vol 64 (03) ◽  
pp. 478-484 ◽  
Author(s):  
Thomas Exner ◽  
Douglas A Triplett ◽  
David A Taberner ◽  
Margaret A Howard ◽  
E Nigel Harris

SummarySix lyophilized plasma samples were sent to 20 “expert” laboratories for assessment of lupus anticoagulant (LA). Four samples contained pooled LA of graded potency mixed with aged normal plasma. One contained LA plus cephalin phospholipid and one contained a nonspecific venom anticoagulant. Sixteen methods were used overall with some participants using up to 8 methods. Results were scored in regard to the known potencies of LA in the samples and other known induced defects.Activated partial thromboplastin time (APTT) tests used by most participants for preliminary screening were relatively sensitive, but non-specific. Platelet or phospholipid neutralization procedures (PNP) appeared to be sensitive and specific but showed a non-linear response to increased LA content. Kaolin clotting time (KCT) tests showed the most sensitive response to increased LA content but the weaker LA were not scored as abnormal by most laboratories as the samples may have contained platelet fragments. Other commonly used tests such as the tissue thromboplastin inhibition (TTI) test and the dilute Russell’s viper venom test (DRVVT) were carried out somewhat inconsistently. The variability in performance of tests in different laboratories indicates that standardization of methodology is urgently required.Generally it seemed that most clotting tests were “bypassed” by the addition of phospholipid to a known LA-positive sample in apparently direct proportion to their sensitivity. Sample preparation, especially prevention of contamination with activated platelets is a vital preliminary part in the assay of LA.


Author(s):  
Himanshi Vashisht ◽  
Sanjay Bharadwaj ◽  
Sushma Sharma

Code refactoring is a “Process of restructuring an existing source code.”. It also helps in improving the internal structure of the code without really affecting its external behaviour”. It changes a source code in such a way that it does not alter the external behaviour yet still it improves its internal structure. It is a way to clean up code that minimizes the chances of introducing bugs. Refactoring is a change made to the internal structure of a software component to make it easier to understand and cheaper to modify, without changing the observable behaviour of that software component. Bad smells indicate that there is something wrong in the code that have to refactor. There are different tools that are available to identify and emove these bad smells. A software has two types of quality attributes- Internal and external. In this paper we will study the effect of clone refactoring on software quality attributes.


TAPPI Journal ◽  
2011 ◽  
Vol 10 (7) ◽  
pp. 29-34
Author(s):  
TEEMU PUHAKKA ◽  
ISKO KAJANTO ◽  
NINA PYKÄLÄINEN

Cracking at the fold is a quality defect sometimes observed in coated paper and board. Although tensile and compressive stresses occur during folding, test methods to measure the compressive strength of a coating have not been available. Our objective was to develop a method to measure the compressive strength of a coating layer and to investigate how different mineral coatings behave under compression. We used the short-span compressive strength test (SCT) to measure the in-plane compressive strength of a free coating layer. Unsupported free coating films were prepared for the measurements. Results indicate that the SCT method was suitable for measuring the in-plane compressive strength of a coating layer. Coating color formulations containing different kaolin and calcium carbonate minerals were used to study the effect of pigment particles’ shape on the compressive and tensile strengths of coatings. Latices having two different glass transition temperatures were used. Results showed that pigment particle shape influenced the strength of a coating layer. Platy clay gave better strength than spherical or needle-shaped carbonate pigments. Compressive and tensile strength decreased as a function of the amount of calcium carbonate in the coating color, particularly with precipitated calcium carbonate. We also assessed the influence of styrene-butadiene binder on the compressive strength of the coating layer, which increased with the binder level. The compressive strength of the coating layer was about three times the tensile strength.


TAPPI Journal ◽  
2009 ◽  
Vol 8 (6) ◽  
pp. 24-28
Author(s):  
CORY JAY WILSON ◽  
BENJAMIN FRANK

TAPPI test T811 is the specified method to ascertain ECT relative to box manufacturer’s certification compliance of corrugated fiberboard under Rule 41/ Alternate Item 222. T811 test sample heights were derived from typical board constructions at the time of the test method’s initial development. New, smaller flute sizes have since been developed, and the use of lighter weight boards has become more common. The T811 test method includes sample specifications for typical A-flute, B-flute, and C-flute singlewall (and doublewall and triplewall) structures, but not for newer thinner E-flute or F-flute structures. This research explores the relationship of ECT sample height to measured compressive load, in an effort to determine valid E-flute and F-flute ECT sample heights for use with the T811 method. Through this process, it identifies challenges present in our use of current ECT test methods as a measure of intrinsic compressive strength for smaller flute structures. The data does not support the use of TAPPI T 811 for ECT measurement for E and F flute structures, and demonstrates inconsistencies with current height specifi-cations for some lightweight B flute.


2001 ◽  
Author(s):  
R. Lawrence ◽  
C. Coffey ◽  
Z. Zhuang ◽  
D. Campbell
Keyword(s):  

2001 ◽  
Author(s):  
L. Janssen ◽  
M. Luinenburg ◽  
H. Mullins ◽  
T. Nelson
Keyword(s):  

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