Results 171 to 180 of about 31,598,850 (295)

Navigating Chinese-led economic integration: a comparative study of commercial dispute resolution and public policy exceptions in Cambodia, Pakistan and Thailand. [PDF]

Front Sociol
Yaseen M, Phattanasin K, Pathak S.
europepmc   +1 more source

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

How the HTAR will contribute to a value‐based decision‐making for medicinal products across the EU

British Journal of Clinical Pharmacology, EarlyView.
The European Union Health Technology Regulation 2021/2282 (HTAR) introduces joint assessment of health technologies (including medicinal products and medical devices) across EU Member States. It was signed into law in 2021 and came into full force in January 2025.
Roisin Adams, Michal Stanak
wiley   +1 more source

Correction: Sociological study of religiosity in post-atheist Kazakhstan. [PDF]

Front Sociol
Zabirova A, Seitakhmetova N, Zhandossova S, Nurov M.   +3 more
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

Regulatory harmonization: Evolution, globalization and future directions

British Journal of Clinical Pharmacology, EarlyView.
Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm, Elaine Y. L. Blair, Christine Y. Lu   +2 more
wiley   +1 more source

Response to Letter to Editor: Comment on "Revisiting the Relationship Between Legal Awareness and Safe Abortion Utilization". [PDF]

Health Sci Rep
Baruwa OJ, Banchani E, Somefun OD.
europepmc   +1 more source

An ETH‐LAD trip with unfavourable consequences: A case report

British Journal of Clinical Pharmacology, EarlyView.
Numerous analogues of the psychedelic and internationally controlled hallucinogen LSD have been described; however, only a limited number have been systematically investigated. This report presents the first case with an analytically confirmed ingestion of ETH‐LAD (6‐ethyl‐6‐nor‐lysergic acid diethylamide), the N‐ethyl derivative of LSD.
Johannes Nadler, Michaela Sommer, Annette Zschiesche, Anne Stürzebecher, Christina Grumann, Volker Auwärter, Maren Hermanns‐Clausen   +6 more
wiley   +1 more source

Implementation and use of risk minimization control tools in the EU: A multistakeholder survey

British Journal of Clinical Pharmacology, EarlyView.
Aims This study characterized stakeholders' experiences with national implementation of risk minimization control tools (RMCTs), such as healthcare professional qualification, healthcare facility accreditation and medical intervention prior to treatment initiation, for eight medicinal products across eight European Union countries. Methods We conducted
Sharon C. M. Essink, Iris R. Joosse, Maximilian Salcher‐Konrad, Melanie Walter, Elena Deligianni, Dimitra Tsioumela, Christos Kontogiorgis, Elita Poplavska, Iluta Žīgure, Christina E. Hoeve, Teresa Leonardo Alves, Ella D. van Vliet, Renato Ferreira‐da‐Silva, Ana Kodrič, Mitja Kos, Juan Erviti, Marta Gutiérrez‐Valencia, Luis Carlos Saiz, Sofia Kälvemark Sporrong, Emelie Karlsson, Christine Leopold, Marie L. De Bruin   +21 more
wiley   +1 more source

Paediatric clonidine medication errors: Findings from a multicentre French study

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to describe the characteristics of medication errors involving clonidine in paediatric patients and reported to French Network of Pharmacovigilance and Poison Control Centres. Methods This retrospective observational study analysed clonidine‐related medication errors reported between 1985 and June 2024 in patients under 12 years ...
Eve‐Marie Thillard, Anthony Facile, Marion Lepelley, Morgane Cellier, Laurent Chouchana, Sophie Gautier, Ramy Azzouz, Thierry Vial, Annie‐Pierre Jonville‐Bera   +8 more
wiley   +1 more source