Essays about: "clinical trials regulation"

Found 4 essays containing the words clinical trials regulation.

  1. 1. Kliniska prövningar i akuta situationer inom EU/EES enligt förordningen om kliniska prövningar

    University essay from Uppsala universitet/Institutionen för farmaceutisk biovetenskap

    Author : Jenny Hiller; [2023]
    Keywords : clinical trials in emergency situations; clinical trials regulation; clinical trials; The Regulation EU No 536 2014 Article 35; article 35;

    Abstract : Bakgrund: Förordningen (EU) nr 536/2014 artikel 35 reglerar kliniska prövningar i akuta situationer. Lagen gäller inom EU/EES sedan januari 2022 och tillåter inkludering av kritiskt sjuka patienter med uppskjutet informerat samtycke, vilket innebär att den första prövningsspecifika interventionen görs innan försökspersonen eller deras juridiska ombud samtycker till deltagande i prövningen. READ MORE

  3. 2. Molecular Characterization of High β-Glucan Lines in Oats

    University essay from Lunds universitet/Tillämpad biokemi

    Author : Abhinav Majumdar; [2022]
    Keywords : Applied biochemistry; Oats; β-Glucan; Dietary fibres; Arbinoxylan; Biology and Life Sciences;

    Abstract : Oats (Avena sativa) are part of the cereal whole grain family, and their production is on the rise for the past few years due to extensive research done on the health benefits it can provide to humans. ScanOats project in Sweden is one of the research groups across the world that has done extensive work on oats. READ MORE

  4. 3. Evaluering av graded glucose infusion som metod för utvärdering av β-cellsfunktion hos häst

    University essay from SLU/Dept. of Clinical Sciences

    Author : Linda Nyqvist; [2022]
    Keywords : ekvint metabolt syndrom; GGI; reproducerbarhet; β-cellsfunktion; häst;

    Abstract : Ekvint metabolt syndrom (EMS) kännetecknas av en samling fysiologiska förändringar som bland annat predisponerar hästar för endokrin fång. Centralt i begreppet är insulindysreglering, som beskriver störningar i insulinutsöndringen, så som hyperinsulinemi och insulinresistens. READ MORE

  5. 4. Commercially Confidential Information - A Reviewed Understanding of the European Disclosure Regime for Medicinal Products

    University essay from Lunds universitet/Juridiska institutionen; Lunds universitet/Juridiska fakulteten

    Author : Ola Borre; [2018]
    Keywords : EU law; Administrative Law; Private International Law; Law and Political Science;

    Abstract : Over the last couple of decades, the European Union has enacted several pieces of legislation to improve insight into its agencies and institutions. This trend has been particularly significant for the pharmaceutical industry, as documents submitted to the EMA in order to have medicinal products approved have been increasingly subjected to public access requirements. READ MORE