Results 141 to 150 of about 365,578 (233)

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

Phonological Feature Abstraction Before 6 Months: Amodal Recognition of Place of Articulation Across Multiple Consonants. [PDF]

Dev Sci
Altuntas E, Best CT, Kalashnikova M, Götz A, Burnham D.   +4 more
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

Speech Sound Acquisition in Urdu-Speaking Children.

Folia Phoniatr Logop
Ambreen S, To CKS.
europepmc   +1 more source

Arabic consonant length perception depends on the relative speech rate of the distal context. [PDF]

PLoS One
Heffner CC, Al-Thowaini BM, Rytting CA.
europepmc   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

How we should measure orthographic depth: Or should we? [PDF]

Psychon Bull Rev
Schmalz X, Rueckl JG, Siegelman N.
europepmc   +1 more source

Exploring new avenues: Psychedelic‐assisted therapy for young people

British Journal of Clinical Pharmacology, EarlyView.
Rates of mental illness in young people are increasing, whereas the development of novel mental health treatments has not significantly progressed. Psychedelic‐assisted therapy, using substances such as psilocybin and 3,4‐methylenedioxymethamphetamine (MDMA), has shown potential in the treatment of mental illnesses in the adult population, including ...
Ioanna Artemis Vamvakopoulou, Dasha Nicholls, David J. Nutt, Martina Di Simplicio   +3 more
wiley   +1 more source

Speech Therapy in an Adult With Cleft Lip and Palate: A Clinical Case Study. [PDF]

Perspect ASHA Spec Interest Groups
Munday JH, Braden MN, Cho DY, Fujiki RB.
europepmc   +1 more source

Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink, Rosanne E. Huisman, Jan‐Peter van Wieringen, H. J. M. J. (Ineke) Crijns, Florence P. A. M. van Hunsel, Anneke L. M. Passier, Sander Borgsteede, A. C. G. (Toine) Egberts, Laura M. Yates, Eugène P. van Puijenbroek   +9 more
wiley   +1 more source