Results 191 to 200 of about 981,328 (290)

Pharmacokinetics of dolutegravir, tenofovir and lamivudine during venous–venous extracorporeal membrane oxygenation (VV‐ECMO): A case report

British Journal of Clinical Pharmacology, EarlyView.
While providing potentially life‐saving cardiorespiratory support for critically ill patients, extracorporeal membrane oxygenation (ECMO) may detrimentally affect pharmacokinetic (PK) performance and concurrent drug efficacy and safety. We describe a patient with Pneumocystis jirovecii pneumonia (PJP) in the context of acquired immunodeficiency ...
Tom C. Zwart, Emiel Leegwater, Thomas H. Ottens, Emile F. Schippers, Erik B. Wilms, David M. Burger, Cees van Nieuwkoop, Liesbeth B. E. Bosma   +7 more
wiley   +1 more source

Promoting resilience and sexual and reproductive health among adolescent migrants: a comprehensive approach. [PDF]

Front Psychiatry
Georgalis A, Thomson R.
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

Entropy-Based Patent Valuation: Decoding "Costly Signals" in the Food Industry via a Robust Entropy-TOPSIS Framework. [PDF]

Entropy (Basel)
Li X, Liu W, Liang X, Zhou A.
europepmc   +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

Evidence-based informed consent forms for total knee arthroplasty and anaesthesia: development and pilot study. [PDF]

J Orthop Surg Res
Zacher S, Lauberger J, Ates DM, Bäthis H, Böhmer A, Bühn S, Kaulbert A, Mathes T, Oerder S, Rosenau H, Steckelberg A, Steffen F, Weise A, Lühnen J.   +13 more
europepmc   +1 more source

Pharmacokinetic‐pharmacodynamic modelling of risankizumab using chronic plaque psoriasis real‐world data

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Risankizumab is a high‐cost biologic treatment for chronic plaque psoriasis, an immune‐mediated inflammatory disease presenting with painful red scaly skin lesions. Inter‐individual heterogeneity in treatment response may be better addressed with personalised rather than fixed dosing. We sought to develop a pharmacokinetic/pharmacodynamic (
Charlotte M. Thomas, Jessica Ruoheng Wei, David Baudry, Zehra Arkir, Bola Coker, Tejus Dasandi, Kingsley Powell, Monica Arenas‐Hernandez, Jenny Leung, Krystal Rawstron, Chioma Nwaogu, Richard Woolf, Andrew E. Pink, Jonathan Barker, Joseph F. Standing, Catherine H. Smith, Satveer K. Mahil   +16 more
wiley   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Athlete data sovereignty: addressing the legal and policy gaps in sports technology. [PDF]

Front Sports Act Living
Kwon JW.
europepmc   +1 more source

Consistency and clarity of pharmacogenomic guidance in UK medicine patient information leaflets: A cross‐sectional analysis

British Journal of Clinical Pharmacology, EarlyView.
Pharmacogenomic (PGx) information has the potential to support the safe and effective use of medicines, yet there is uncertainty about how this information can be best communicated to patients. Summaries of product characteristics (SmPCs) and patient information leaflets (PILs) for all UK‐approved medicines with strong evidence supporting a PGx ...
Parth Narlawar, Chloe Ratcliffe, Videha Sharma, William G. Newman, Munir Pirmohamed, John McDermott   +5 more
wiley   +1 more source