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Registration of medicines
Šubová, Irena ; Solich, Jan (advisor) ; Portych, Jiří (referee)
Marketing authorization of medicinal products Mgr. Irena Šubová Charles University in Prague, Faculty of Pharmacy Hradec Králové, Department of Social and Clinical Pharmacy Marketing authorization of medicinal products is process when the quality, safety and efficiency of product are checked based on submitted documentation. Registration in the Czech Republic is according to law No.79/1997 and No.473/2000 and it is harmonized with directives and regulations of European Union. A generic drug is medicinal product which has same qualitative and quantitative composition, as for active substances and same dose as the original formulation and whose bioequivalence with the original formulation has been proven by relevant studies of bioavailability. Structure of documentation describing medicinal program have been given united format, so called Common Technical Document (CTD). Documentation is divided in to 5 modules. Module 1 includes Administrative Information and Prescribing Information and its content is given by national drug regulatory agencies, Module 2 includes Common Technical Document Summaries, Module 3 includes Quality data, Module 4 includes Non-clinical study reports and Module 5 Clinical Study Reports. Important part of Module 1 is Summary of Product Characteristics, which is approved summarized...
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The Professional Czech Music Company (A String Quartet)
Syllová, Andrea ; Portych, Jiří (advisor) ; Perglerová, Marka (referee)
The main topic of this dissertation is professional Czech music ensembles, namely string quartets. The work deals shortly with the development of Czech string tradition. Firstly, it examines music and repertoire of classicism, which was the period when the quartet music appeared for the first time and started to develop gradually. It introduces the first teachers of chamber music of conservatoires in both Prague and Brno, and their pupils who spread further this tradition. Moreover, the work tries to portray the differences between the situations in the two biggest centres, Prague and Brno. This work presents also the music life o f 1900, and it predominantly provides some information on the music organisations at that time: Union for Chamber Music, Czech Association for Chamber Music or Juvenile Club. The most important ensembles of the first half of the twentieth century are introduced; among the discussed ones is The Czech Quartet, then The SevCikovo-Lhotskéf The Heroldovo, The Ondrickovo and The Zikovo Quartet. The ensembles that were active during World War Two are also mentioned, as well as the contemporary ones. Powered by TCPDF (www.tcpdf.org)
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The Personality of Ralph Vaughan Williams with a view to an Analysis of his 8th Symphony
Velická, Helena ; Bělohlávková, Petra (advisor) ; Nedělka, Michal (referee) ; Portych, Jiří (referee) ; Pecháček, Stanislav (referee)
Vaughan Williams was an extraordinary ordinary man and a very great composer who has reached during his lifetime the hearts of a very large section of his countrymen. Music was the mainspring of his being and he put all that he knew into his music. The essential importance of this composer consists in symphonic and song work. He is an author of nine symphonies, ballet, film music and five operas but the very best success reached he with his choral works. He found the basis and inspiration in the music of his own land and has devoted a good deal of energy to the collecting and arranging of folksongs. The influence of that association on his work is obvious but it is egually evident that he is far from being merely an imitator of folksong. The accents of traditional melody appeal to him but his mode of expression is his own - it is wholly personal and it makes use of passing dissonance in a way which no study of folk melodies could possibly have suggested. He was a friend and admirer of romantics but showed distaste for several favourite romantic emotions. His style is half traditional half modern and that is why his music is understandable. Powered by TCPDF (www.tcpdf.org)
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