Results 221 to 230 of about 65,875 (292)

Medico-legal integration of molnupiravir rapid deployment during the COVID-19 pandemic: Emergency use authorization, clinical evidence, and risk of viral mutagenesis. [PDF]

One Health
Tsai TH.
europepmc   +1 more source

ADMINISTRATIVE AND LEGAL ASPECTS PROTECTION OF DEFENSE OF UKRAINE

Scientific works of National Aviation University. Series: Law Journal "Air and Space Law", 2019
openaire   +1 more source

Beyond the label: Rethinking off‐label drug use in paediatrics. Towards a scientifically grounded and safer future for paediatric pharmacotherapy

British Journal of Clinical Pharmacology, EarlyView.
Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +3 more
wiley   +1 more source

Indian psychiatrist at the crossroads of transgender care: Gatekeeper, advocate, or redundant authority? [PDF]

Indian J Psychiatry
Sutar RF.
europepmc   +1 more source

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

British 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, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

The policy construction of illegal markets: Exploring variation, success, failure, and unintended consequences. [PDF]

Proc Natl Acad Sci U S A
Paoli L, Reuter P.
europepmc   +1 more source

Acute toxicity of ADB‐CHMINACA ‐ a case series of patients with pronounced central nervous symptoms including the posterior reversible encephalopathic syndrome

British Journal of Clinical Pharmacology, EarlyView.
Aim This report presents a series of 16 patients who were admitted to the emergency department following confirmed intake of the potent synthetic cannabinoid ADB‐CHMINACA. Methods The cases are drawn from a prospective observational study following the recreational use of synthetic cannabinoids.
Maren Hermanns‐Clausen, Michaela Sommer, Annette Zschiesche, Verena Angerer, Martin Scheu, Florian Eyer, Johannes Nadler, Volker Auwärter   +7 more
wiley   +1 more source

Industrializing traditional medical knowledge in China: an integrated governance framework for addressing institutional fragmentation. [PDF]

Front Public Health
Wang Y, Xu K, Hua D.
europepmc   +1 more source

Precision medicine in paediatrics: Progress and priorities

British Journal of Clinical Pharmacology, EarlyView.
Precision medicine is revolutionizing personalized healthcare, advancing both diagnostics and therapeutics at an unprecedented pace. Reviewing the paediatric applications of pharmacometrics, pharmacogenomics and advanced therapy medicinal products highlights not only the relevance of these exciting innovations to frontline care but also the significant
Nicola Husain, Claire Booth, Joseph F. Standing, Charlotte I. S. Barker   +3 more
wiley   +1 more source