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International pharmacopoeia monographs : antimalarial dosage forms / J.C. WesselsWessels, Johanna Christina January 2010 (has links)
Malaria is a disease affecting millions of people in 109 malarious countries and
territories, causing approximately one million deaths annually. In 2004 one of the
parasites causing human malaria, Plasmodium falciparum, was among the leading
global causes of death from a single infectious agent, especially in Africa (WHO,
2008:23).
Treatment of this disease with single active pharmaceutical ingredients has led to the
emergence of resistant P. falciparum parasites, resulting in the most severe form of
this illness. Alarmingly, the poor quality of commercially available antimalarial
products, especially in Africa, has increasingly been reported as a major cause of
resistance to antimalarials. In Pakistan it was found that a P. falciparum epidemic
that initially was attributed to drug resistance, was actually caused by substandard
sulfadoxine/pyrimethamine products, causing a 50 times higher incidence of malaria
in these areas than elsewhere (Leslie et al., 2009:1758). Other results indicated that
up to 10% of sulfadoxine/pyrimethamine tablets, sampled in six African countries,
failed the assay test, whilst up to 40% failed the USP dissolution test. Furthermore,
the World Health Organization (WHO) reported that 20 - 90% of products failed
quality requirements during 1999 and 2000 in seven African countries (WHO,
2003:263).
Cases like these have raised the awareness of the vast number of inferior products
that are being distributed. The subsequent need for establishing mechanisms to proactively
detect substandard medicines, specifically antimalarials, easily and
effectively had indirectly led to the origin of this study, long before it was formally
undertaken.
Testing monographs for pharmaceutical products are developed to formalise, or
standardise, the regulation of pharmaceutical dosage forms. Problems have,
however, been reported with regards to the inadequacy of existing antimalarial
monographs in assuring quality medicines, fit for their intended use. The WHO had requested the Research Institute for Industrial Pharmacy,
incorporating the Centre for Quality Assurance of Medicines (RIIP®/CENQAM®), both
operating at the Potchefstroom Campus of the North–West University, to develop
monographs for three immediate–release antimalaria dosage forms, namely
amodiaquine tablets, sulfadoxine/pyrimethamine fixed–dose combination tablets and
mefloquine tablets. The undertaking of these projects, to develop specifications for
the quality control of these pharmaceutical products, formed the object of this
research study.
Data had been accumulated since 2000, as a result of continuous requests by the
WHO to help solve problems that had been experienced with analytical test
methods, especially from manufacturers. These requests either led to the refinement
of existing methods, or to the development of new ones. The success with
which these outcomes were implemented worldwide, finally led to the decision to
publish these research findings under the umbrella of this project.
The proud product is a comprehensive package of tests for three commercial
antimalarial products, the outcomes of which are hoped to contribute towards the
combat against resistance formation to these important disease fighters. / Thesis (Ph.D. (Pharmaceutics))--North-West University, Potchefstroom Campus, 2011.
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International pharmacopoeia monographs : antimalarial dosage forms / J.C. WesselsWessels, Johanna Christina January 2010 (has links)
Malaria is a disease affecting millions of people in 109 malarious countries and
territories, causing approximately one million deaths annually. In 2004 one of the
parasites causing human malaria, Plasmodium falciparum, was among the leading
global causes of death from a single infectious agent, especially in Africa (WHO,
2008:23).
Treatment of this disease with single active pharmaceutical ingredients has led to the
emergence of resistant P. falciparum parasites, resulting in the most severe form of
this illness. Alarmingly, the poor quality of commercially available antimalarial
products, especially in Africa, has increasingly been reported as a major cause of
resistance to antimalarials. In Pakistan it was found that a P. falciparum epidemic
that initially was attributed to drug resistance, was actually caused by substandard
sulfadoxine/pyrimethamine products, causing a 50 times higher incidence of malaria
in these areas than elsewhere (Leslie et al., 2009:1758). Other results indicated that
up to 10% of sulfadoxine/pyrimethamine tablets, sampled in six African countries,
failed the assay test, whilst up to 40% failed the USP dissolution test. Furthermore,
the World Health Organization (WHO) reported that 20 - 90% of products failed
quality requirements during 1999 and 2000 in seven African countries (WHO,
2003:263).
Cases like these have raised the awareness of the vast number of inferior products
that are being distributed. The subsequent need for establishing mechanisms to proactively
detect substandard medicines, specifically antimalarials, easily and
effectively had indirectly led to the origin of this study, long before it was formally
undertaken.
Testing monographs for pharmaceutical products are developed to formalise, or
standardise, the regulation of pharmaceutical dosage forms. Problems have,
however, been reported with regards to the inadequacy of existing antimalarial
monographs in assuring quality medicines, fit for their intended use. The WHO had requested the Research Institute for Industrial Pharmacy,
incorporating the Centre for Quality Assurance of Medicines (RIIP®/CENQAM®), both
operating at the Potchefstroom Campus of the North–West University, to develop
monographs for three immediate–release antimalaria dosage forms, namely
amodiaquine tablets, sulfadoxine/pyrimethamine fixed–dose combination tablets and
mefloquine tablets. The undertaking of these projects, to develop specifications for
the quality control of these pharmaceutical products, formed the object of this
research study.
Data had been accumulated since 2000, as a result of continuous requests by the
WHO to help solve problems that had been experienced with analytical test
methods, especially from manufacturers. These requests either led to the refinement
of existing methods, or to the development of new ones. The success with
which these outcomes were implemented worldwide, finally led to the decision to
publish these research findings under the umbrella of this project.
The proud product is a comprehensive package of tests for three commercial
antimalarial products, the outcomes of which are hoped to contribute towards the
combat against resistance formation to these important disease fighters. / Thesis (Ph.D. (Pharmaceutics))--North-West University, Potchefstroom Campus, 2011.
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Validering van 'n gerekenariseerde simulasietegniek vir die meting van kliëntediensvaardighede / The validation of a computerized simulation technique for the measurement of customer services skillsBotha, Mathilda Martha Maria 12 1900 (has links)
Gehaltediens lei tot effektiwiteit in enige organisasie. Die meting hiervan behoort 'n prioriteit te
wees, maar geskikte, gevalideerde, wetenskaplike meetinstrumente hiervoor bestaan nie.
Die algemene doel van die navorsing was die validering van 'n gerekenariseerde simulasietegniek
("Business Principles Orientation") vir die meting van klientediensvaardighede.
In die literatuuroorsig is klientediens gedefinieer en vyf dimensies van gehaltediens gei:dentifiseer.
Deur empiriese navorsing is die gerekenariseerde simulasietegniek ("Business Principles
Orientation") se meting van klientediensvaardighede bepaal, deur dit afte neem op 'n steekproef
van 28 kassiere in 'n supermark. Hierdie instrument is gekorreleer met die Servqual-vraelys.
Die resultate dui op 'n swak verband tussen die veranderlikes van die Servqual-vraelys en
gerekenariseerde simulasietegniek. Hiervolgens is die gerekenariseerde simulasietegniek en die
ontwikkelingsverslag wat dit verskaf, nie geldig in die meting van klientdiensvaardighede nie.
Aanbevelings ten opsigte van die instrument se verdere verfyning en navorsing word geformuleer. / Quality service leads to effectiveness in any organisation. The measurement of effectiveness
should be a priority, but suitable, valid and scientific measurement instruments for this purpose
does not exist.
The general aim of the research was the validation of a computerized simulation technique
("Business Principles Orientation") for the measurement of client service skills.
In the literature survey, quality service was defined and five dimensions of quality service
identified. In the empirical research the measurement of client service skills through the use of the
computerized technique ("Business Priciples Orientation"), was determined by testing it on a
sample of 28 cashiers from a supermarket. This instrument was correlated with the Servqual-questionaire.
The results show little correlation between the variables of the Servqual questionaire and
computerized simulation technique. In terms hereof the computerized simulation technique and
development report that it provides, is not valid in the measurement of client care skills.
Recommendations for further refinement and research pertaining to this instrument is formulated. / Industrial & Organisational Psychology / M.A. (Bedryfsielkunde)
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Validering van 'n gerekenariseerde simulasietegniek vir die meting van kliëntediensvaardighede / The validation of a computerized simulation technique for the measurement of customer services skillsBotha, Mathilda Martha Maria 12 1900 (has links)
Gehaltediens lei tot effektiwiteit in enige organisasie. Die meting hiervan behoort 'n prioriteit te
wees, maar geskikte, gevalideerde, wetenskaplike meetinstrumente hiervoor bestaan nie.
Die algemene doel van die navorsing was die validering van 'n gerekenariseerde simulasietegniek
("Business Principles Orientation") vir die meting van klientediensvaardighede.
In die literatuuroorsig is klientediens gedefinieer en vyf dimensies van gehaltediens gei:dentifiseer.
Deur empiriese navorsing is die gerekenariseerde simulasietegniek ("Business Principles
Orientation") se meting van klientediensvaardighede bepaal, deur dit afte neem op 'n steekproef
van 28 kassiere in 'n supermark. Hierdie instrument is gekorreleer met die Servqual-vraelys.
Die resultate dui op 'n swak verband tussen die veranderlikes van die Servqual-vraelys en
gerekenariseerde simulasietegniek. Hiervolgens is die gerekenariseerde simulasietegniek en die
ontwikkelingsverslag wat dit verskaf, nie geldig in die meting van klientdiensvaardighede nie.
Aanbevelings ten opsigte van die instrument se verdere verfyning en navorsing word geformuleer. / Quality service leads to effectiveness in any organisation. The measurement of effectiveness
should be a priority, but suitable, valid and scientific measurement instruments for this purpose
does not exist.
The general aim of the research was the validation of a computerized simulation technique
("Business Principles Orientation") for the measurement of client service skills.
In the literature survey, quality service was defined and five dimensions of quality service
identified. In the empirical research the measurement of client service skills through the use of the
computerized technique ("Business Priciples Orientation"), was determined by testing it on a
sample of 28 cashiers from a supermarket. This instrument was correlated with the Servqual-questionaire.
The results show little correlation between the variables of the Servqual questionaire and
computerized simulation technique. In terms hereof the computerized simulation technique and
development report that it provides, is not valid in the measurement of client care skills.
Recommendations for further refinement and research pertaining to this instrument is formulated. / Industrial and Organisational Psychology / M.A. (Bedryfsielkunde)
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