Results 241 to 250 of about 398,598 (315)

Why and how do we perform physical examination(s) in clinical trials? A use case of drug intervention trials in type 2 diabetes mellitus

British Journal of Clinical Pharmacology, EarlyView.
Aims The aim of this study was to determine the purpose and use of physical examination (PE) in phase 3 and 4 drug interventional clinical trials within type 2 diabetes mellitus. Methods A total of 226 clinical trial protocols identified from the ClinicalTrials.gov database were systematically reviewed by five researchers.
Julia Kopanz, Amy Rogers, Lina Pérez‐Breva, Emily Hall, Prashasthi Devaiah, Isla S. Mackenzie, Bart Lagerwaard, Diederick E. Grobbee, Mira G. P. Zuidgeest, on behalf of the Trials@Home consortium   +9 more
wiley   +1 more source

Interleukin (IL)‐5, Eosinophils and IL‐5 Pathway Inhibitors in Eosinophilic Granulomatosis with Polyangiitis.

Arthritis &Rheumatology, Accepted Article.
Alvise Berti, Christian Pagnoux
wiley   +1 more source

AZD0449, an inhaled JAK1 inhibitor, in healthy participants and patients with mild asthma

British Journal of Clinical Pharmacology, EarlyView.
Aims Inhaled corticosteroids (ICS) plus bronchodilator are recommended for the treatment of asthma. Targeting the JAK1‐dependent pathway may be an alternative for asthma management in patients with incomplete response to ICS. The aim of this study was to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD0449, a
Anna Lundahl, Rod Hughes, Joachim Almquist, David Close, Jukka Mäenpää, Ulrika Tehler, Tina Jellesmark Jensen, Szilárd Nemes, Anne‐Kristina Mercier, Zala Jevnikar, Pablo Forte Soto, Dave Singh   +11 more
wiley   +1 more source

Adverse immunostimulation in early phase clinical trials: Key findings and recommendations based on the investigator's clinical experience

British Journal of Clinical Pharmacology, EarlyView.
Problem setting The emergence of therapeutic proteins has coincided with an increase of acute adverse immunostimulation (AIS). AIS has occured in clinical trials despite compliance with regulatory guidelines on preclinical evaluation and its incidence is anticipated to increase even further.
Juliette A. van den Noort, Marella C. E. van Ruissen, Lisanne C. A. Smidt, Naomi B. Klarenbeek, Philip H. K. Kremer, Manon A. A. Jansen, Jacobus Burggraaf, Joop M. A. van Gerven, Matthijs Moerland   +8 more
wiley   +1 more source

Ileal bile acid transporter inhibitors in Alagille syndrome and Progressive Familial Intrahepatic Cholestasis: A systematic review into dose–response

British Journal of Clinical Pharmacology, EarlyView.
Ileal bile acid transporter inhibitors (IBATi), including maralixibat and odevixibat, are a novel approach to the treatment of paediatric cholestatic liver diseases, such as Alagille syndrome (ALGS) and different forms of progressive familial intrahepatic cholestasis (PFIC).
Alise D. E. de Groot, Cristina Chiadò, Jos G. W. Kosterink, Willem S. Lexmond, Paola Mian, Henkjan J. Verkade   +5 more
wiley   +1 more source

Pregabalin dependence, withdrawal, suicidality and psychosis reports: A disproportionality analysis of the Australian adverse events database

British Journal of Clinical Pharmacology, EarlyView.
Aims Globally, Australia has the highest per capita consumption rate of pregabalin, commonly prescribed for neuropathic pain. Emerging evidence suggests pregabalin may be associated with the onset or recurrence of several potentially life‐threatening psychiatric events in some individuals.
Amy G. McNeilage, Ali Gholamrezaei, Bridin Murnion, Suzanne Nielsen, Claire E. Ashton‐James   +4 more
wiley   +1 more source

Dosing Biologic Drugs for Patients with Obesity: One Size Does NOT Fit All

Arthritis &Rheumatology, Accepted Article.
Stephen J. Balevic, Daniel Gonzalez, Bernd Meibohm   +2 more
wiley   +1 more source

An experimental medicine protocol for exploring the haemodynamic effects of dual agonism at the glucagon‐like peptide‐1 and glucagon receptor in healthy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims Glucagon‐like peptide‐1 (GLP‐1) and glucagon dual receptor agonists are in clinical development for a range of metabolic conditions, including type 2 diabetes and obesity. The cardiovascular actions at these receptors are well studied, but less is known about their combination.
James Goodman, Victoria E. Parker, Carmel M. McEniery, Giovanni Di Stefano, Annette Hubsch, Evangelia Vamvaka, Jo Helmy, Fotini Kaloyirou, Navazh Jalaludeen, Peter Barker, Lutz Jermutus, Joseph Cheriyan, Philip Ambery, Ian B. Wilkinson   +13 more
wiley   +1 more source

Population pharmacokinetic modelling revealed large variability in oromucosal absorption of Δ9‐tetrahydrocannabinol in older patients with poor appetite

British Journal of Clinical Pharmacology, EarlyView.
Aim Cannabis‐based medicines are gaining interest and being explored for new therapeutic indications, many of which commonly affect older medical patients. As most previous studies of the population pharmacokinetics of cannabinoids have been performed in healthy adults, this study aimed to investigate the population pharmacokinetics of Δ9 ...
Ida Klitzing Storgaard, Rikke Lundsgaard Nielsen, Morten Baltzer Houlind, Olivia Bornæs, Louise Westberg Strejby Christensen, Aino Leegaard Andersen, Helle Gybel Juul‐Larsen, Lillian Mørch Jørgensen, Torben Breindahl, Baker Nawfal Jawad, Izzet Altintas, Ove Andersen, Trine Meldgaard Lund   +12 more
wiley   +1 more source

Population pharmacokinetics and exposure–response analysis of durvalumab in patients with resectable stage II to IIIB (N2) NSCLC in the phase III AEGEAN study

British Journal of Clinical Pharmacology, EarlyView.
Aims In the AEGEAN study, perioperative durvalumab plus platinum‐based neoadjuvant chemotherapy for patients with resectable stage II to IIIB (N2) non‐small‐cell lung cancer (NSCLC) demonstrated a favourable benefit–risk profile. This study evaluated population pharmacokinetics (PopPK) and exposure–response (ER) relationships of durvalumab in patients ...
Xiaoying Zhao, Junjie Ding, Jiajia Zhao, Ling Zhang, Aburough Abegesah, Yu‐qian Zhang, Cathy O'Brien, Gary J. Doherty, Allen C. Chen, KyoungSoo Lim, Song Ren, Peiming Ma, Diansong Zhou   +12 more
wiley   +1 more source