Results 181 to 190 of about 277,288 (290)

Prognostic Value of the TLM3 Biomarker Panel for Early Fibrosis Development in MASLD Within the General Population. [PDF]

open access: yesLiver Int
van Son KC   +18 more
europepmc   +1 more source

Expedited Approval in Oncology: A Study of European Regulators' Perspectives and Trade‐Offs

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The purpose of this study was to describe the perspectives and trade‐offs of EU regulators about expedited approvals for treatments of patients with advanced cancer. The study consisted of a cross‐sectional survey with assessors and experts from the network of the European Medicines Agency (EMA).
Francesco Pignatti   +5 more
wiley   +1 more source

Introduction

open access: yesCardiovascular Innovations and Applications, 2016
Ezra A. Amsterdam
doaj   +1 more source

Relationship between Dose, Factor IX Activity Levels and Bleeding Probability for rIX‐FP Prophylaxis in Hemophilia B: A Repeated Time‐to‐Event Analysis

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
In hemophilia B, pharmacokinetic (PK)‐guided dosing of extended half‐life factor IX (EHL‐FIX) concentrates can secure targeted FIX exposure. Target FIX activity levels in plasma should be individually set primarily taking bleeding tendency into account, alongside the presence of target joints, physical activity, and preferred dosing schedules. In other
Sjoerd F. Koopman   +4 more
wiley   +1 more source

Effectiveness and Safety of Personalized Cholic Acid Treatment in Patients With Bile Acid Synthesis Defects. [PDF]

open access: yesJ Inherit Metab Dis
Polak Y   +8 more
europepmc   +1 more source

Optimizing Patient Registries for Regulatory Decision Making ‐ Key Learnings From an HMA/EMA Multistakeholder Workshop

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
The Joint Heads of Medicines Agencies and European Medicines Agency's (HMA/EMA) big data initiative paves the way for better integration of real‐world data, including data from patient registries, into regulatory decisions on medicines. This article focuses on the outcome of a two‐day multistakeholder workshop organized by EMA in 2024, which explored ...
Kelly Plueschke   +24 more
wiley   +1 more source

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