Sökning: "in vitro diagnostic products"

Hittade 4 uppsatser innehållade orden in vitro diagnostic products.

  1. 1. Approved medicinal products with potential companion diagnostic tests : An Inventory of the Swedish/European drug market

    Master-uppsats, Uppsala universitet/Institutionen för farmaceutisk biovetenskap

    Författare :Katrin Andersson; [2023]
    Nyckelord :CDx; Companion Diagnostic; IVDMD; In-vitro diagnostic medical devices; Regulation EU 2017 746;

    Sammanfattning : The newly introduced regulation (EU) 2017/746 aims to make In Vitro Diagnostic Medical Devices (IVDMD), which include companion diagnostic tests (CDx), a widespread method of authorising medicinal products in the European market. However, European SmPCs (Summary of Product Characteristics) currently do not explicitly refer to the term or classify tests associated with medicinal products as CDx. LÄS MER

  3. 2. Evaluation of method for function control of test assay’s complementing and signaling enzymes

    Kandidat-uppsats, Uppsala universitet/Institutionen för medicinsk cellbiologi

    Författare :Alva Strand; [2022]
    Nyckelord :Nucleoside 5´-Diphosphate Kinase NdPK ; Adenosine 5´-Triphosphate ATP ; Rate-limiting enzyme; ß-Nicotinamide Adenine Dinucleotide ß-NADH ; Enzymatic specific activity.;

    Sammanfattning : Nucleoside 5'-Diphosphate Kinase (NdPK EC 2.7.4.6) is an enzyme (phosphotransferase) with extraordinary characteristics due to its unique ability to transfer phosphor groups to interconvert all nucleoside di- and triphosphates as a part of the DNA synthesis. LÄS MER

  4. 3. Konsekvenserna av (EU) 2017/746- förordningen på tillverkning och användning av medicintekniska produkter för in vitro-diagnostik inom Karolinska Universitetssjukhuset

    Kandidat-uppsats, KTH/Medicinteknik och hälsosystem

    Författare :Soziar Bamyr Hanssen; Rosemarie Ohanyan; [2021]
    Nyckelord :IVDD; IVDR; regulations; in-house production; distribution; manufacturing; IVDD; IVDR; regelverk; egentillverkning; distribution; tillverkning;

    Sammanfattning : In collaboration with the Karolinska University Hospital, this research was carried out with the aim of executing a consequence analysis of the new regulation (EU) 2017/746. The consequences of the regulation regarding access, distribution, manufacturing and in-house production of in vitro diagnostic products were examined for various departments at the Karolinska University Hospital. LÄS MER

  5. 4. Upphandling av medicintekniska produkter inom sjukvården i Sverige

    Kandidat-uppsats, KTH/Skolan för teknik och hälsa (STH)

    Författare :Elin Andersson; Emma Filipsson; [2017]
    Nyckelord :The Public Procurement Act; public procurement; allocation criteria; in vitro diagnostic products; Swedish healthcare; medical technology; innovation; Lagen om offentlig upphandling; offentliga upphandlingar; tilldelningskriterier; in vitro-diagnostiska produkter; Sveriges sjukvård; medicinsk teknik; innovation;

    Sammanfattning : Since 1994, the Public Procurement Act has undergone changes aimed to improve the procurement process and promoting innovation. In order to promote innovation there are a number of government agencies that offer financial assistance, especially to small business with innovative ideas. LÄS MER