Results 171 to 180 of about 41,376 (260)

Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post‐authorization studies, 2022–2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu, William A. Blumentals, Froilan G. Celzo, G. Caleb Alexander, Lingyun Zhou, Juhaeri Juhaeri, Corinne Jouquelet‐Royer, Jian‐Yu E   +7 more
wiley   +1 more source

A rare missense p.C125Y mutation in the TNFRSF1A gene identified in a Chinese family with tumor necrosis factor receptor-associated periodic fever syndrome. [PDF]

Front Genet
Qian M, Zhou J, Wu J, Zhang H, Yu S, Xu H, Yang Y, Zhou F, Yang Q, Shao L, Zhang W, Jiang N, Ruan Q.   +12 more
europepmc   +1 more source

Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway

British Journal of Clinical Pharmacology, EarlyView.
Aim This study aimed to compare how Norwegian healthcare professionals (HCPs) and consumers reported the same adverse event (AE) following immunization with vaccines against COVID‐19 during the COVID‐19 pandemic. Specifically, we aimed to compare the extent to which HCPs and consumers reported information relevant for assessing the causal relationship ...
Tommy Emil Dzus, Johaina Sarrage, Hilde Samdal, François Montastruc, Elena Rocca   +4 more
wiley   +1 more source

Pharmacokinetics and safety of tezepelumab in children with mild, moderate or severe asthma and adolescents with mild‐to‐moderate asthma

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Tezepelumab is a human monoclonal antibody that blocks the activity of thymic stromal lymphopoietin and is approved for adolescents and adults with severe asthma. This analysis assessed pharmacokinetics (PK), pharmacodynamics and safety of tezepelumab up to 85 days postdose in adolescents and children.
Anna Lundahl, Jonathan Grigg, Lubna Abuqayyas, Piotr Kuna, Gillian Hunter, Beata Pawlikowska, Jacob Leander, Michael Levin, Atul Gupta, James Paton, Katharine C. Pike, Jane R. Parnes, Gun Almqvist, Stephanie L. Roseti, on behalf of the study investigators   +14 more
wiley   +1 more source

Impact of cumulative glucocorticoid exposure on vancomycin clearance in hospitalized children: A retrospective cohort study

British Journal of Clinical Pharmacology, EarlyView.
Prior glucocorticoid exposure is associated with modestly increased vancomycin clearance in hospitalized children, partly mediated by renal function and inflammation and may contribute to subtherapeutic early drug exposure. Abstract Introduction Augmented renal clearance (ARC) can lead to subtherapeutic vancomycin exposure in children.
Kouki Tomari, Ruud H. J. Verstegen, Cintia Cruz, Erin Chung, Aleena Azim, Shinya Ito, Tamorah R. Lewis   +6 more
wiley   +1 more source

Periodic fever syndromes and the autoinflammatory diseases (AIDs). [PDF]

J Transl Autoimmun, 2020
Marino A, Tirelli F, Giani T, Cimaz R.
europepmc   +1 more source

N‐acetylcysteine for non‐paracetamol‐induced acute liver failure in children: A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Non‐surgical treatment of acute liver failure (ALF) is primarily supportive and depends on the underlying cause. While N‐acetylcysteine (NAC) is proven effective in paracetamol‐induced ALF, its potential benefits in non‐paracetamol ALF for paediatric patients remain unclear.
Alise D. E. de Groot, Désanka M. Stoppels, Arno R. Bourgonje, Willemien F. J. Hof, Martin C. J. Kneyber, Daan J. Touw, Henkjan J. Verkade, Paola Mian   +7 more
wiley   +1 more source

Canakinumab treatment real world evidence in 3 monogenic periodic fever syndromes in 2009-2022: an interim analysis using the French JIR cohort database. [PDF]

Arthritis Res Ther
Koné-Paut I, Georgin-Lavialle S, Belot A, Jover M, Pouriel M, Lacoin L, Pillet P, Hentgen V.   +7 more
europepmc   +1 more source

Pharmacometric evaluation of pre‐referral rectal artesunate in children with severe malaria

British Journal of Clinical Pharmacology, EarlyView.
Aims Parenteral artesunate is the preferred first‐line treatment for severe malaria. Pre‐referral rectal artesunate suppositories are recommended where parenteral treatment is inaccessible. In this study, we compared dihydroartemisinin exposure and model‐predicted early parasite clearance following rectal artesunate and intravenous artesunate in ...
Ayorinde Adehin, Marie A. Onyamboko, Caterina Fanello, Nicholas J. White, Nicholas P. J. Day, Richard M. Hoglund, Joel Tarning   +6 more
wiley   +1 more source

Purification of Advanced Therapeutics by Flow‐Through Pseudo‐Affinity Chromatography: Bi‐Specific mABs, Fc Fusion Proteins, and Adeno‐Associated Viruses

Biotechnology and Bioengineering, EarlyView.
ABSTRACT Modern biopharmaceutical manufacturing requires purification platforms capable of processing structurally and functionally diverse products while addressing the challenge of removing persistent and high‐risk host cell proteins (HCPs).
Wenning Chu, Eduardo Barbieri, Arianna Minzoni, Shriarjun Shastry, Jacob P. LeBarre, Qingbo Shu, Taufika Williams, Xuanwen Li, Divya Chandra, Xuankuo Xu, Jerome Bill, David Roush, Joseph Taris, Patrick Gilbert, Andre Kiesewetter, Oliver Rammo, Michael Schulte, Christopher Major, Trina Mouchahoir, Steven Cramer, Cristiana Boi, Ruben G. Carbonell, Abraham Lenhoff, Stefano Menegatti   +23 more
wiley   +1 more source