In the last two decades there has been a shift in the approach to evaluating the benefit–risk (BR) profiles of medicinal products from an unstructured, subjective, and inconsistent, to a more structured and objective, process. This article describes ...

concept paper proposes the development of a single on the clinical evaluation of indicated for treatment of bacterial infections.

This is a key point in the evaluation of a medicine where the initial viewpoints are integrated and consolidated. This will lead to a single assessment report which will comprise an overview of the assessment and a list of concerns and objections.

The review of the benefits and the risks associated with a medicinal product is called benefit–risk assessment. One of the conditions for a medicinal product to receive marketing authorization is to demonstrate a positive benefit–risk balance in which the benefits outweigh the risks.

revision addresses biomarker-guided medicinal product development, recent designs in oncology (such as designs of master protocol studies), as well as clarifying and structural changes throughout the text.

This review discusses the methodological challenges to the evaluation of advanced therapy medicinal products (ATMPs) by the UK National Institute for Health and Care Excellence (NICE). We analysed the health technology appraisals (both published and ...

Dec 8, 2020 · Contemporary structured benefit-risk evaluation aims at providing an objective assessment of the benefit-risk profile of medicinal products and a higher transparency for decision making purposes. The use of a descriptive framework should be the preferred starting point for a structured benefit-risk assessment.

Contemporary structured benefit–risk evaluation aims at providing an objective assessment of the benefit–risk profile of medicinal products and a higher transparency for decision making purposes. The use of a descriptive framework should be the preferred starting point for a structured benefit–risk assessment.

Objective: The goal of this paper is to propose an additional methodology to evaluate and valuate innovative drugs from a broader perspective by applying concepts from business valuation, when the ICER exceeds the threshold.

Each month, the European Medicines Agency's (EMA) publishes an updated list of medicines for human use currently under evaluation by EMA’s Committee for Medicinal Products for Human Use (CHMP) to obtain a marketing authorisation in the European Union (EU).