Results 131 to 140 of about 12,120,147 (284)

Actors and Roles in EU Disability Law

This open access book looks at the development and consolidation of EU disability law as a distinct field of enquiry. It provides novel approaches to studying EU disability law. In a departure from other books on the topic, it takes a contextual approach,

core   +1 more source

Scientific expertise in European food law

, 2015
Technological progress rimes in food area with risk. Since the 1990s, a series of health risks have led to the adoption of standards and agreements in national, european and international levels to mentoring activities in food area. The European food safety authority was created in that purpose.
openaire   +1 more source

Status of oncology drugs with a conditional approval: A cross‐sectional comparison of the Food and Drug Administration and Health Canada

British Journal of Clinical Pharmacology, EarlyView.
Aims This study looks at the status of the same drugs conditionally approved by the Food and Drug Administration and Health Canada for the same oncology indication. Methods Lists of oncology drugs with a conditional approval from the Food and Drug Administration and Health Canada were generated and drug pairs with the same indication were matched ...
Joel Lexchin
wiley   +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

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

The implementation of European animal welfare standards in Turkish animal protection legislation and case law. [PDF]

Front Vet Sci
Uyar Ç.
europepmc   +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

Implications of the new US AI framework in medicine. [PDF]

Commun Med (Lond)
Armoundas AA.
europepmc   +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

How do secondary schools in England talk about modern languages? A corpus‐assisted discourse analysis of school websites

British Educational Research Journal, EarlyView.
Abstract Situating the study within an ecological perspective on language education, this article examines how secondary schools in England present Modern Languages (MLs) on official school websites. Focusing on 44 schools in Local Authorities with the lowest percentage average entry for the Languages pillar of the EBacc, we built a text database ...
Zhu Hua, Yunpeng Du, Elin Arfon
wiley   +1 more source