Results 231 to 240 of about 20,047 (298)

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

Precision medicine in paediatrics: Progress and priorities

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

Impact of parameter settings on the estimation of drug exposure with the individualized dispensing patterns method

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim To assess the impact of parameter settings when using the individualized dispensing patterns (IDP) method to estimate exposure duration from dispensing data. Methods We conducted a cohort study using a 2% representative sample of the French healthcare insurance database from 2013 to 2022.
Laëtitia Gosselin   +8 more
wiley   +1 more source

The impact of medication shortages on paediatric care: A retrospective impact analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Medication shortages are a growing global concern, with potentially greater consequences in paediatric patients because of the limited availability of safe, evidence‐based and appropriately formulated medication. This study aimed to evaluate the impact of medication shortages on paediatric patients by assessing the suitability and safety of ...
Maaike Johanna Rutten ‐ van Kranenburg   +6 more
wiley   +1 more source

Incident low‐dose quetiapine use in adults newly diagnosed with depression in primary care: A nationwide register‐based study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to investigate the incidence of low‐dose quetiapine initiation and associated factors in adults newly diagnosed with depression in primary care. Methods We obtained medication dispensing records, primary and secondary care diagnoses and employment status for antipsychotic‐naïve individuals aged 16–65 newly diagnosed with ...
Laura Purra   +5 more
wiley   +1 more source

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