Results 261 to 270 of about 56,414 (330)

A scoping review of thresholds for responder and time‐to‐event analysis of patient‐reported outcomes in breast cancer trials

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Patient‐reported outcomes (PROs) are essential for assessing clinical benefit and tolerability from the patient's perspective. In oncology trials, PRO data analysis often involves responder and time‐to‐event analyses, which depend on predefined thresholds to determine clinically meaningful change.
Anna Margarete Maria Thurner   +5 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

Subjective memory concerns and AD/ADRD plasma biomarker associations in HABS-HD. [PDF]

open access: yesAlzheimers Dement (Amst)
Thomas KR   +6 more
europepmc   +1 more source

Therapeutic drug monitoring of antimicrobials in a paediatric setting: A retrospective single‐centre study

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Paediatric pharmacokinetics differ significantly from adults due to age‐related physiological changes, necessitating precise dose adjustments. However, data on therapeutic drug monitoring (TDM) implementation in paediatric setting remain limited.
Gianluca Gazzaniga   +20 more
wiley   +1 more source

Hair analysis of formoterol as a novel tool to assess long‐term inhalation medication adherence: Data from the TRICOLON trial

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aim The aim of this paper is to examine inhaled formoterol concentrations in hair and assess the potential of hair analysis as a tool for measuring long‐term adherence, by validation with objective data from digital inhalers. Methods Hair samples and digital inhaler data were collected from patients with COPD in 10 hospitals in the Netherlands as part ...
Liz J. A. Cuperus   +44 more
wiley   +1 more source

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