Results 131 to 140 of about 3,406 (225)

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

Migrating longitudinal African mental health data from staging to the OMOP common data model within the INSPIRE network datahub. [PDF]

Front Psychiatry
Bhattacharjee T, Mugotitsa B, Ochola M, Momanyi R, Andeso P, Amadi D, Mailosi D, Najjemba L, Greenfield J, Mabe K, Slaymaker E, Todd J, Kiragga A, INSPIRE Network .   +13 more
europepmc   +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

Trial-ready external controls for gene therapy: The MATCH cohort in maple syrup urine disease. [PDF]

Cell Rep Med
Brigatti KW, Rodrigues A, Sweigert E, Williamson J, Koehler A, Meier GL, Poskitt LE, Carson VJ, Robinson D, Strauss KA.   +9 more
europepmc   +1 more source

The effect of mild and moderate hepatic impairment on the pharmacokinetics, safety and tolerability of balcinrenone

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Balcinrenone (previously AZD9977) is a novel selective non‐steroidal mineralocorticoid receptor antagonist (MRA) with a differential mechanism of action relative to approved MRAs. The aim of this trial was to assess the pharmacokinetics, safety and tolerability of balcinrenone in participants with mild and moderate hepatic impairment ...
Anna L. Eriksson, Deeyen Karsanji, Bonifride Tuyishimire, Joanna Parkinson, Maria Heijer, Tadeusz Pawlik, Judith Hartleib‐Geschwindner, Maria Leonsson‐Zachrisson, Hans Ericsson   +8 more
wiley   +1 more source

Genome-wide association studies of brain diffusion kurtosis imaging phenotypes. [PDF]

EBioMedicine
Fu J, Wang J, Xue H, Wang M, Zhang B, Zhu W, Qiu S, Geng Z, Cui G, Zhang Q, Yu Y, Liao W, Gao B, Xu X, Han T, Yao Z, Li MJ, Liu F, Liang M, Wang S, Xu Q, Xu J, Zhang P, Li W, Shi D, Wang C, Lui S, Yan Z, Chen F, Zhang J, Li J, Shen W, Miao Y, Wang D, Xian J, Gao JH, Zhang X, Xu K, Zuo XN, Zhang L, Ye Z, Cheng J, Qin W, Zhang H, Yu C, CHIMGEN Consortium.   +45 more
europepmc   +1 more source

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera, Giusi Forastiero, Andrea Logreco, Alessia Proietti, Antonio Galluccio, Carlotta Lunghi, Elisabetta Poluzzi, Fabrizio De Ponti   +7 more
wiley   +1 more source

A university‐certified course on dossier assessment for regulatory scientists in Africa—Reporting on our 5‐year experience

British Journal of Clinical Pharmacology, EarlyView.
Aim The shortage of trained clinical assessors in African National Regulatory Authorities (NRAs) poses a challenge to effective regulatory decision‐making. Developed in line with the World Health Organization's (WHO) Global Competency Framework (WHO‐GCF), a university‐certified short course, Dossier assessment for clinical assessors in Africa, was ...
Stephanie Leigh, Boitumelo Semete‐Makokotlela, Ivana Škrnjug‐Yudov, David Mukanga, Delese Mimi Darko, Eric Karikari‐Boateng, Peter Stonier, Luther Gwaza, Precious Matsoso, Bernd Rosenkranz, Birka Lehmann, Arnold G. Vulto, John G. Woodland, Shabir Banoo, Frieda Shigwedha, Maphutheho Selikane, Unathi Mabona‐Mgoqi, Asare Yeboah, Ntombi Mthembu, Goonaseelan ( Colin) Pillai   +19 more
wiley   +1 more source

A scientometric dataset on pharmaceuticals and illicit drugs (including cocaine) in the water resources of Latin America and the Caribbean (1990-2024). [PDF]

Data Brief
Roveri V, Correia AT, Toma W, Rodrigues AZ, Pereira CDS, Guimarães LL.   +5 more
europepmc   +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