Results 221 to 230 of about 6,816,256 (279)

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

open access: yesBritish 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   +3 more
wiley   +1 more source

Efficacy, safety and cost‐effectiveness of CAR‐T therapy

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
CAR T‐cells demonstrate high efficacy in blood cancers, including ALL, MM and DLBCL. Innovations target solid tumours despite challenges such as antigen escape. Combination therapies enhance the delivery and infiltration of CAR T cells. Toxicity, cost and resistance remain major barriers to clinical use.
Emina Karahmet Sher   +7 more
wiley   +1 more source

Regulatory harmonization: Evolution, globalization and future directions

open access: yesBritish 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   +2 more
wiley   +1 more source

Model‐informed optimal dose selection of golcadomide in combination with R‐CHOP in patients with previously untreated aggressive B‐cell lymphoma

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Golcadomide is a potential first‐in‐class oral CELMoD™ agent for the treatment of lymphoma. This study aims to develop model‐informed drug development (MIDD) approaches to support optimal dose selection of golcadomide in combination with immunotherapy rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R‐CHOP) in alignment with ...
Xirong Zheng   +7 more
wiley   +1 more source

Safety outcomes of antidiabetic medications: A comprehensive review of the EU summaries of product characteristics and international clinical practice guidelines

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Aims Information on the safety profile of antidiabetic medications is essential for informed treatment decisions in type 2 diabetes mellitus. Although this information is available in regulatory documents of individual drugs, a comprehensive overview across all approved antidiabetics is lacking.
David Liang   +5 more
wiley   +1 more source

Dose‐related propofol resistance in COVID‐19 patients: Altered drug plasma levels, mechanistic insights from neuronal‐derived extracellular vesicles and miRNA analysis

open access: yesBritish Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Critical care for COVID‐19 patients presents unique challenges, particularly in sedation management. Patients demonstrate notable dose‐related resistance to propofol, potentially due to complex pharmacokinetic alterations. Emerging evidence suggests that plasma extracellular vesicle‐associated miRNA represents valuable predictive ...
Debora Curci   +10 more
wiley   +1 more source

Listening to young children with disabilities: Experiences of quality in mainstream primary education

open access: yesBritish Educational Research Journal, EarlyView.
Abstract All children should have access to quality education through a child‐centred pedagogy. An inclusive, child‐centred pedagogy uses a strength‐based view of children that recognises each child as unique and competent, providing children with multiple opportunities to explore and learn at their own pace.
Katherine Gulliver
wiley   +1 more source

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