Results 201 to 210 of about 986,928 (308)

Evaluating AI decision tools in Ecuador's courts: efficiency, consistency, and uncertainty in legal judgments. [PDF]

open access: yesFront Artif Intell
Rodríguez-Salcedo E   +6 more
europepmc   +1 more source

Setting up mother–infant pair lactation studies with biobanking for research according to regulatory requirements

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Within the ConcePTION project we set out to design two mother–infant pair studies collecting breast milk and plasma from the mother and plasma from the infant (for metformin and prednisolone) in order to demonstrate the premises and conditions for investigating potential drug transfer in association with breastfeeding.
Mats Hansson   +11 more
wiley   +1 more source

Development and Validation of the Future Career Insecurity Scale (FCIS) in Law Students. [PDF]

open access: yesBehav Sci (Basel)
Lan C   +9 more
europepmc   +1 more source

Population pharmacokinetic modelling of amoxicillin in human breast milk—A contribution from the ConcePTION project

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Amoxicillin, a widely used β‐lactam antibiotic, requires improved pharmacokinetic characterization during breastfeeding. This study used a population pharmacokinetic (PopPK) approach to model amoxicillin concentrations in breast milk, identify variability sources and estimate infant exposure, applying worst‐case scenarios.
Sarah Baklouti   +9 more
wiley   +1 more source

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

open access: yesBritish 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   +3 more
wiley   +1 more source

The vulnerability of refugees and asylum seekers in Italy: Insights from a nationwide survey. [PDF]

open access: yesPLoS One
Mendola D   +12 more
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

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

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