Development of an innovative technology for the manufacturing of an anti-neoplastic product, a medicinal product, which is inhibitory to different receptors, and a variety of tyrostic receptors. (Q79922): Difference between revisions

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(‎Removed claim: summary (P836): The main objective of the project is to increase the availability of modern medical treatment for cancer patients.The main objective of the project will be achieved through the implementation of industrial research, such as:— predictive studies, -studies on the technology for the production of a laboratory series -study on optimising the process technology during a batch of large laboratory medicine, -development and validation of analytical m...)
Property / summary
The main objective of the project is to increase the availability of modern medical treatment for cancer patients.The main objective of the project will be achieved through the implementation of industrial research, such as:— predictive studies, -studies on the technology for the production of a laboratory series -study on optimising the process technology during a batch of large laboratory medicine, -development and validation of analytical methods for the control of the quality of the medicinal product, -study on the development of a batch (pilot) batch test, -stability studies of batches of large-laboratory and pilot medicinal products, -testing of the bioequivalence of a medicinal product, and the following development work:Work on the continuous analysis of the patent situation throughout the whole research project, -analysis of the study area of the project area and analysis of the AMF documentation for the active substance and analysis of samples of the active substance — work on the dossier necessary for the process of registration of the medicinal product.This work has been divided into ten main work packages (Work Package).As a result of which a technology will be developed to produce an antineoplastic medicine in the form of oral capsules containing the active substance Sniatinib. (English)
 
Property / summary: The main objective of the project is to increase the availability of modern medical treatment for cancer patients.The main objective of the project will be achieved through the implementation of industrial research, such as:— predictive studies, -studies on the technology for the production of a laboratory series -study on optimising the process technology during a batch of large laboratory medicine, -development and validation of analytical methods for the control of the quality of the medicinal product, -study on the development of a batch (pilot) batch test, -stability studies of batches of large-laboratory and pilot medicinal products, -testing of the bioequivalence of a medicinal product, and the following development work:Work on the continuous analysis of the patent situation throughout the whole research project, -analysis of the study area of the project area and analysis of the AMF documentation for the active substance and analysis of samples of the active substance — work on the dossier necessary for the process of registration of the medicinal product.This work has been divided into ten main work packages (Work Package).As a result of which a technology will be developed to produce an antineoplastic medicine in the form of oral capsules containing the active substance Sniatinib. (English) / rank
Normal rank
 

Revision as of 10:33, 14 October 2020

Project in Poland financed by DG Regio
Language Label Description Also known as
English
Development of an innovative technology for the manufacturing of an anti-neoplastic product, a medicinal product, which is inhibitory to different receptors, and a variety of tyrostic receptors.
Project in Poland financed by DG Regio

    Statements

    country
    Poland
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    EU contribution
    2,108,031.5 zloty
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    505,927.56 Euro
    exchange rate to Euro
    0.24 Euro
    point in time
    13 January 2020
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    budget
    3,627,490.0 zloty
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    870,597.6 Euro
    exchange rate to Euro
    0.24 Euro
    point in time
    13 January 2020
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    co-financing rate
    58.11 percent
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    start time
    1 August 2016
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    end time
    31 July 2020
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    beneficiary name (string)
    VIPHARM SPÓŁKA AKCYJNA
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    beneficiary
    Q2510800
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    coordinate location

    52°32'46.3"N, 21°12'26.3"E
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    summary
    Głównym celem projektu jest zwiększenie dostępności nowoczesnej terapii leczniczej dla pacjentów onkologicznych. Cel główny projektu zostanie osiągnięty dzięki wykonaniu badań przemysłowych, takich jak: -badania preformulacyjne, -badania nad technologią wytworzenia serii laboratoryjnych -badania nad optymalizacją technologii procesu w trakcie serii wielkolaboratoryjnych leku, -opracowanie i walidacja metod analitycznych do kontroli jakości produktu leczniczego, -badania nad wytworzeniem serii rejestracyjnych (pilotażowych), -badania stabilności wytworzonych serii wielkolaboratoryjnych i pilotażowych produktu leczniczego, -badanie równoważności biologicznej produktu leczniczego, oraz dzięki przeprowadzeniu następujących prac rozwojowych: -prace nad ciągłą analizą sytuacji patentowej podczas całego projektu badawczego, -analiza literaturowa obszaru projektu -analiza dokumentacji ASMF dla substancji czynnej oraz analiza próbek substancji czynnej -prace nad dokumentacją niezbędną do przeprowadzenia procesu rejestracji produktu leczniczego. Powyższe prace zostały podzielone na dziesięć głównych pakietów prac (Work Package). W wyniku których zostanie opracowana technologia wytwarzania leku przeciwnowotworowego w postaci doustnych kapsułek zawierających substancję czynną Sunitynib. (Polish)
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    Identifiers

    Polish Kohesio ID
    POIR.01.02.00-00-0037/15
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