22 research outputs found
Biomarkers for nonclinical infusion reactions in marketed biotherapeutics and considerations for study design
Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-Derived Pharmaceuticals
OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis
Preservation of effect and the regulatory approval of new treatments on the basis of non-inferiority trials
Diagnostic and prognostic assessment of suspected drug‐induced liver injury in clinical practice
Idiosyncratic drug-induced liver injury (DILI) is a challenging liver disorder because it can present with a range of phenotypes, mimicking almost every other hepatic disease, and lacks specific biomarkers for its diagnosis. Hence, a confident DILI diagnosis is seldom possible as it relies on the precise establishment of a temporal sequence between the exposure to a given prescription drug or sometimes hidden herbal product/over the counter medication as well as the exclusion of other aetiologies of liver disease. However, an accurate diagnosis is of most importance, as prompt withdrawal of the causative agent is essential in DILI management. Indeed, DILI can be severe and even fatal or in a fraction of cases evolve to chronic damage, but specific biomarkers for predicting mortality/liver transplantation or a chronic outcome in the very early phases of DILI are not yet available. In this article, we discuss the best diagnostic and prognostic approach of a DILI suspicion by judiciously choosing and interpreting the standard tests currently used in clinical practice
