Results 241 to 250 of about 479,258 (314)

Population pharmacokinetics and pharmacodynamics of canagliflozin in paediatric patients with type 2 diabetes mellitus

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Canagliflozin was recently approved in type 2 diabetes mellitus (T2DM) patients ≥10 and <18 years old as a single agent dosed once daily (QD) or in a fixed‐dose combination with metformin dosed twice daily (BID). We characterize canagliflozin pharmacokinetics in paediatric patients with T2DM, compare estimated individual and simulated ...
Nele Goeyvaerts, Per Olsson Gisleskog, Martine Neyens, Juan José Perez Ruixo, Saberi Rana Ali, Iolanda Cirillo, Oliver Ackaert   +6 more
wiley   +1 more source

Sustained pharmacodynamic effects of S‐ketamine on cortical excitability and resting‐state brain activity: A randomized, placebo‐controlled trial

British Journal of Clinical Pharmacology, EarlyView.
Aims This study aimed to investigate a set of pharmacodynamic biomarkers reflecting acute, delayed and sustained central nervous system effects of S‐ketamine, used as a tool compound for rapid‐acting antidepressant activity, with the goal of informing biomarker strategies for delayed antidepressant effects.
Catherine M. K. E. de Cuba, Annika A. de Goede, Joost. C. van Mechelen, Laura G. J. M. Borghans, Liam van der Aa, Erik Olofsen, Maria J. Juachon, Robert J. Doll, Amy Gillespie, Catherine J. Harmer, Gabriël E. Jacobs, Jules A. A. C. Heuberger   +11 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

Safety and pharmacokinetics of mosliciguat, a new, inhaled soluble guanylate cyclase activator, in healthy adult subjects

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Mosliciguat (BAY 1237592), the first soluble guanylate cyclase (sGC) activator in a dry powder inhaler (DPI), could potentially treat pulmonary hypertension with a more targeted delivery than systemic sGC stimulators. We report safety and tolerability of mosliciguat in healthy men.
Johannes Nagelschmitz, Soundos Saleh, Sandra Ligges, Melanie Seidel‐Greven, Eva Becker‐Pelster, Sylvia M. Nikkho, Stefanie Boxnick, Wolfgang Timmer   +7 more
wiley   +1 more source

Counting your chickens before they hatch: improvements in an untreated chronic pain population, beyond regression to the mean and the placebo effect. [PDF]

Pain Rep
Sean M, Coulombe-Lévêque A, Nadeau W, Charest AC, Martel M, Léonard G, Tétreault P.   +6 more
europepmc   +1 more source

Development of a nalmefene formulation suitable for a community‐use auto‐injector

British Journal of Clinical Pharmacology, EarlyView.
Aim Time to onset of reversal is critical when treating opioid‐induced respiratory depression and hypoxia. This study aimed to develop a formulation of the opioid antagonist nalmefene with an increased absorption rate and reduced time to onset of reversal following intramuscular administration. Methods Several absorption enhancers were screened in rats,
Alessandra Cipriano, Manjunath S. Shet, Hugh Huang, Ronnie Ortiz, Garth T. Whiteside, Glen Apseloff, Stephen C. Harris   +6 more
wiley   +1 more source

[Placebo effect in the treatment with antidepressants : Implications for the scientific evaluation and clinical use of pharmaceutical treatments of depression]. [PDF]

Nervenarzt
Rief W, Kube T.
europepmc   +1 more source

Gabapentinoids‐duloxetine combination therapy for chronic pain: A mechanism oriented rational to bridge theoretical knowledge and real life setting

British Journal of Clinical Pharmacology, EarlyView.
Chronic pain represents a complex debilitating condition that extends beyond the protective function of physiological pain, often persisting as an independent disease entity. Chronic primary and secondary pain syndromes reflect a multifaceted continuum involving nociceptive, neuropathic and nociplastic mechanisms.
Stefania Nobili, Maurizio Evangelista, Elena Lucarini, Elena G. Giugliano, Carla Ghelardini, Laura Micheli, Lorenzo Di Cesare Mannelli   +6 more
wiley   +1 more source

Semaglutide vs. liraglutide and incidence of diabetes and cardiovascular disease: A target trial emulation using real‐world data

British Journal of Clinical Pharmacology, EarlyView.
Aims The glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) semaglutide and liraglutide are approved for chronic weight management. Both drugs also have favourable effects on the risk of developing diabetes and cardiovascular disease (CVD) compared with placebo, but their comparative effectiveness for these outcomes is unclear.
Ethan J. Cannon, Wendy Wang, Faye L. Norby, Rob F. Walker, Shalini Kulasingam, Lisa S. Chow, Joel F. Farley, Pamela L. Lutsey   +7 more
wiley   +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