Results 261 to 270 of about 285,048 (302)

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola   +5 more
wiley   +1 more source

Adverse events in bedaquiline‐ and pretomanid‐based regimens for drug‐resistant tuberculosis from trial, implementation and pharmacovigilance studies

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract The availability of safety data, particularly concerning adverse events (AEs) associated with the new shorter regimen for drug‐resistant tuberculosis (TB) containing a bedaquiline–pretomanid‐based regimen, is still limited. This systematic review aims to provide a comprehensive and updated analysis of AEs related to this new regimen by ...
Nisa Maria   +4 more
wiley   +1 more source

Leveraging an Online Dashboard to Inform on Infectious Disease Surveillance: A case Study of COVID-19 in Kenya

open access: yes
Mwanga MJ   +20 more
europepmc   +1 more source

The Surveillance of Infectious Diseases

JAMA: The Journal of the American Medical Association, 1983
Surveillance is the collection, collation, and analysis of data and the dissemination to those who need to know so that an action can result. This article describes the clinician's critical role in disease reporting and outlines the benefits of surveillance to clinical practice.
S B, Thacker, K, Choi, P S, Brachman
openaire   +3 more sources

Surveillance of infectious diseases in the Arctic

Public Health, 2016
This study reviews how social and environmental issues affect health in Arctic populations and describes infectious disease surveillance in Arctic Nations with a special focus on the activities of the International Circumpolar Surveillance (ICS) project.We reviewed the literature over the past 2 decades looking at Arctic living conditions and their ...
M. Bruce, T. Zulz, A. Koch
openaire   +2 more sources

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