Results 231 to 240 of about 709,311 (322)

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

British 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, Ida Björkgren, Jenny Svedenkrans, Helena Backman, Jarl Hellman, Linda Englund‐Ögge, Mikaela Magnusson, Inger Lindström, Andrea Wutte, Erica Sundell, Pawel Baranczewski, Laura Shaughnessy   +11 more
wiley   +1 more source

Blastic plasmacytoid dendritic cell neoplasm following Langerhans cell histiocytosis. [PDF]

JAAD Case Rep
Goto M, Akatsuka T, Uchiyama E, Urabe H, Shibamiya A, Nakaseko C, Komuta M, Hayashi Y, Hamada T, Sugaya M.   +9 more
europepmc   +1 more source

Exploration of Pathways for Integrating Health into All Policies from the Perspective of Environmental Health Governance in China. [PDF]

China CDC Wkly
Yang X, Fang H, Wang Q, Xu D.
europepmc   +1 more source

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

British 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, Miriam G. Mooij, Matthijs de Hoog, Saskia N. de Wildt   +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

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

The Enactment and Implementation of Korea's Digital Medical Products Act: A Comparative Study Exploring Policy Implications. [PDF]

J Korean Med Sci
Chung J, Shin Y, Kim G, Lee M, Shin J.
europepmc   +1 more source

Use of antiemetics in early pregnancy 2012–2022: A cross‐sectional study

British Journal of Clinical Pharmacology, EarlyView.
Aim Nausea and vomiting in pregnancy impact quality of life, yet many pregnant women feel dismissed by healthcare professionals, despite the safety of first‐line antiemetic treatments for both mother and fetus. Therefore, this study aims to describe the prevalence of patient‐reported antiemetic use in early pregnancy in Copenhagen, Denmark, the changes
Katrine Bak Wraae, Nanna Roed Ballegaard, Mie Lærkeholm Hede, Line Buchgreitz, Ane Lilleøre Rom, Hanne Kristine Hegaard, Nina Olsén Nathan   +6 more
wiley   +1 more source