Results 141 to 150 of about 14,680 (246)

Tacrolimus exposure during pregnancy in kidney and liver transplantation recipients: A comparison between whole blood and plasma concentration‐to‐dose ratios

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Tacrolimus monitoring is generally performed in whole blood (WB). Most (>85%) of circulating tacrolimus is bound to red blood cells. During pregnancy, WB monitoring might be suboptimal because of physiological changes including increased plasma volume and decreased haematocrit.
Jildau R. Meinderts   +7 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

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

The TIDE project OSCAR [PDF]

open access: yes, 1997
Beijk, CM, Faulkner, A, vanSon, N
core  

Health economic considerations for pharmacogenomic services in the United Kingdom: The Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics

open access: yes
British Journal of Clinical Pharmacology, EarlyView.
Dyfrig A. Hughes   +4 more
wiley   +1 more source

Inflammation‐driven variability in drug metabolism: Insights from voriconazole treatment of HSCT recipients

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Voriconazole is commonly used to prevent fungal infections after haematopoietic stem cell transplantation (HSCT). Although its metabolism is influenced by CYP2C19 genetics and inflammation, their combined effect is rarely considered in clinical practice, and integrated analyses remain limited.
Sylvia D. Klomp   +6 more
wiley   +1 more source

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