Results 111 to 120 of about 39,717 (249)

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

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Comparative efficacy of GLP‐1 RA, tirzepatide and SGLT‐2 inhibitors in metabolic liver disease: A network meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Aim Metabolic liver disease, including nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, is a major cause of chronic liver dysfunction worldwide, creating an urgent need for effective treatments. This systematic literature review (SLR) and network meta‐analysis (NMA) systematically reviews and compares the efficacy and safety ...
Andrej Belančić, Christina Antza, Anastasios Poutachidis, Smaro Palaska, Elvira Meni Maria Gkrinia, Andrea Katrin Faour, Yusuf Ziya Sener, Seher Sener, Rehena Sultana   +8 more
wiley   +1 more source

Type 2 diabetes and the risk of hospitalisation and mortality from seasonal influenza: an observational register-based study in Sweden. [PDF]

BMJ Open
Kjölhede EA, Carlsen HK, Martyn O, Svensson L, Gisslén M, Eliasson B, Eeg-Olofsson K.   +6 more
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

Royal Swedish Academy of Sciences

TRENDS IN THE SCIENCES, 2001
openaire   +2 more sources

Risk of venous thromboembolism after SARS‐CoV‐2 vaccination—Evidence from genome‐wide association study and population‐based observational study

British Journal of Clinical Pharmacology, EarlyView.
Aim We aimed to investigate whether genetic variation is associated with venous thromboembolism after immunization with SARS‐CoV‐2 vaccines. Methods We conducted a genome‐wide association study (GWAS) on cases of venous thromboembolism within 42 days after SARS‐CoV‐2 vaccination, recruited from reports of adverse drug reactions sent to the Swedish ...
Sofia Attelind, Niclas Eriksson, Marco Cavalli, Yiyi Xu, Fredrik Nyberg, Anders Sundström, Mia Wadelius, Pär Hallberg   +7 more
wiley   +1 more source

Genetically Determined Levels of Inflammation-Related Proteins and Functional Outcome After Ischemic Stroke: A Mendelian Randomization Study. [PDF]

J Stroke
Angerfors A, Andersson B, Furutjäll S, Chong M, Jern C, Stanne TM.   +5 more
europepmc   +1 more source

S. aureus colonization and clinical symptoms remain stable upon topical XZ.700 treatment: Results of a double‐blind randomized clinical trial in patients with mild to moderate atopic dermatitis

British Journal of Clinical Pharmacology, EarlyView.
Aim Recovering dysbiosis may improve atopic dermatitis (AD) symptoms. XZ.700 is a recombinant chimeric endolysin that specifically targets Staphylococcus aureus and could be a new treatment option for patients with AD. The aim of this first‐in‐human study was to evaluate the safety, tolerability and efficacy of topical XZ.700 and explore the ...
Laura W. J. van der Meulen, Menthe E. Bergmans, Salma Assil, Naomi Klarenbeek, Marieke L. de Kam, Alexa J. Tibboel, Thorsten Brach, Bjorn L. Herpers, Johan Frieling, Vincent de Jong, Benthe Freyee, Martijn B. A. van Doorn, Robert Rissmann, Tessa Niemeyer–van der Kolk   +13 more
wiley   +1 more source

Gender-Specific Associations Between Tobacco and Tobacco-Free Nicotine Use and Symptoms of Anxiety and Depression in Swedish Adolescents. [PDF]

Tob Use Insights
Andersson J, Hansson M, Ericson M, Adermark L.   +3 more
europepmc   +1 more source