Essays about: "In-vitro diagnostic medical devices"

Found 2 essays containing the words In-vitro diagnostic medical devices.

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

   University essay from Uppsala universitet/Institutionen för farmaceutisk biovetenskap

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

   Abstract : 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. READ MORE

3. 2. Companion Diagnostics Development and Commercialization : A Case Study from the Diagnostics’ Perspective

   University essay from KTH/Hållbarhet och industriell dynamik

   Author : Andreas Nolting; [2015]
   Keywords : Companion diagnostics; in-vitro; EME; FDA; Stratified medicine; Biomarker; Clinical utility; Medical Devices;

   Abstract : The value proposition of Personalized Medicine is to deliver the “right drug, to the right patient, at the right time”. Companion diagnostics is the required tool for Personalized Medicine used to aid clinical decision making with the aim to identify patients who are most suitable for a given treatment approach and to avoid adverse effects. READ MORE