Sökning: "fit-for-purpose analysis"

Hittade 4 avhandlingar innehållade orden fit-for-purpose analysis.

  1. 1. Pharmacometric Investigations of Prediction Precision and Advances of Models for Composite Scale Data

    Författare :Gustaf Wellhagen; Maria C. Kjellsson; Bengt Hamrén; Per Olsson Gisleskog; Uppsala universitet; []
    Nyckelord :MEDICIN OCH HÄLSOVETENSKAP; MEDICAL AND HEALTH SCIENCES; pharmacometrics; modelling; non-linear mixed effects modelling; composite scale data; total score data; total score analysis; precision prediction; bounded integer; bounded integer model; IRT-informed total score analysis; item response theory-informed; mixed models for repeated measures; MMRM; dose-response; dose-response mixed models for repeated measures; DR-MMRM; HbA1c models; fit-for-purpose analysis; clinical trial analysis; Farmaceutisk vetenskap; Pharmaceutical Science;

    Sammanfattning : Clinical trials are needed to evaluate new treatments. In late-stage clinical trials, failures are mostly due to lack of efficacy. Fit-for-purpose analysis methods will likely increase the success rates and advance drug development by providing higher precision to support decisions such as go/no-go, dose selection, or sample size. LÄS MER

  3. 2. Analytical Quality by Design Method Development for Vaccine Characterization

    Författare :Lars Geurink; Catharina Sänger van de Griend; Mikael Hedeland; Martijn Schenning; Iulia Oita; Uppsala universitet; []
    Nyckelord :NATURVETENSKAP; NATURAL SCIENCES; viral vaccines; adenovirus; influenza; polio; COVID; corona; capillary electrophoresis; analytical quality by design; analytical method development; CGE; icIEF; CZE; crude cell suspension analysis; in-process sample analysis; quality control testing; biopharmaceutical characterization; Analytisk farmaceutisk kemi; Analytical Pharmaceutical Chemistry;

    Sammanfattning : Vaccines that are safe, efficacious, and can be rapidly developed are needed to prevent and to react to emerging global infectious disease threats such as influenza, Polio, and Coronavirus diseases. Fast and reliable analytical methods are required without delay to support vaccine process and product development, characterization, and quality control testing. LÄS MER

  4. 3. The health economics of Duchenne muscular dystrophy

    Författare :Erik Landfeldt; Karolinska Institutet; Karolinska Institutet; []
    Nyckelord :;

    Sammanfattning : Duchenne muscular dystrophy (DMD) is a rare neuromuscular disease characterized by progressive muscle degeneration resulting in loss of independent ambulation, serious multisystem complications, and a mean life expectancy at birth of about 25 years. Several therapies are on the horizon for DMD and it has thus become urgent to better understand the health economic context of the disease to enable assessments of cost-effectiveness and inform decisions regarding reimbursement of new health technologies. LÄS MER

  5. 4. Architecting Safe Automated Driving with Legacy Platforms

    Författare :Naveen Mohan; Martin Törngren; Jakob Axelsson; KTH; []
    Nyckelord :TEKNIK OCH TEKNOLOGIER; ENGINEERING AND TECHNOLOGY; TEKNIK OCH TEKNOLOGIER; ENGINEERING AND TECHNOLOGY; architectures; automated driving; autonomous vehicles; methods; processes; tools; functional safety; ISO 26262; diagnostic specifications; platform based design; legacy integration; functional safety concept; preliminary architectural assumptions; uncertainty management; design decisions;

    Sammanfattning : Modern vehicles have electrical architectures whose complexity grows year after year due to feature growth corresponding to customer expectations. The latest of the expectations, automation of the dynamic driving task however, is poised to bring about some of the largest changes seen so far. LÄS MER