Results 181 to 190 of about 12,052 (258)

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

United Nations Partnerships With the Alcohol Industry. [PDF]

open access: yesInt J Health Policy Manag
Yan Leung JY, Casswell S.
europepmc   +1 more source

S. aureus colonization and clinical symptoms remain stable upon topical XZ.700 treatment: Results of a double‐blind randomized clinical trial in patients with mild to moderate atopic dermatitis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Recovering dysbiosis may improve atopic dermatitis (AD) symptoms. XZ.700 is a recombinant chimeric endolysin that specifically targets Staphylococcus aureus and could be a new treatment option for patients with AD. The aim of this first‐in‐human study was to evaluate the safety, tolerability and efficacy of topical XZ.700 and explore the ...
Laura W. J. van der Meulen   +13 more
wiley   +1 more source

Survey on the Working Conditions, Salary, and Job Satisfaction of Employed Veterinarians in Germany. [PDF]

open access: yesVet Sci
Jensen KC   +5 more
europepmc   +1 more source

Case‐malformed signal detection and prioritisation using EUROmediCAT data for pharmacovigilance in pregnancy

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim Many women take medications during pregnancy. However, the risk to the fetus from most medications is uncertain. Congenital anomalies are one of the leading causes of infant death and contribute to long‐term disability. Signal detection methods can be used to systematically identify possible medication–anomaly associations that require further ...
Hannah Johnson   +22 more
wiley   +1 more source

Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim This study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID‐19 during the COVID‐19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship ...
Tommy Emil Dzus   +4 more
wiley   +1 more source

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