Results 171 to 180 of about 3,041 (213)

A Comparison of Regional Decisions for Doses and Administrations of New Drugs: Concordance, Discordance, and Dependencies

Clinical Pharmacology &Therapeutics, EarlyView.
Regional differences in approved drug dosages and administration are shaped by complex factors, including clinical data, prior regulatory decisions, and region‐specific considerations. This study investigated how such factors are associated with variations in approved doses across the United States Food and Drug Administration (FDA), European Medicines
Sachiko Mita, Shunsuke Ono
wiley   +1 more source

Treatment outcomes of zanubrutinib-based regimen in newly diagnosed patients with MYC/BCL2 double-expressor diffuse large B-cell lymphoma: a retrospective multicenter real-world study. [PDF]

Ann Hematol
Lu B, Wang Y, Jin M, Zhang J, Xu X, Zeng Y, Zhao L, Wang H.   +7 more
europepmc   +1 more source

Accelerating Generic Long‐Acting Antiretrovirals for Global HIV Treatment: Workshop Findings and a Roadmap to Access

Clinical Pharmacology &Therapeutics, EarlyView.
The global HIV response aims for widespread availability of affordable, quality‐assured long‐acting antiretroviral (LA ARV) drugs to achieve sustained epidemic control, particularly in low‐ and middle‐income countries. This report summarizes key discussion points, findings, and outcomes from an international workshop on generic LA ARVs, held in ...
Usman Arshad, Lobna Gaayeb, Henry Pertinez, Rajith K. R. Rajoli, Melynda Watkins, Parag Nimbolkar, Simone Perazzolo, Bharat Pagi, Annemarie Wensing, Saye Khoo, Marta Boffito, René Holm, Zack Panos, Imelda Mahaka, Francois Venter, Benny Kottiri, Keith W. Crawford, Rodney J. Y. Ho, Polly Clayden, Paul Domanico, Kimberly Struble, Andrew Owen, Charles Flexner   +22 more
wiley   +1 more source

Continuous physiological monitoring for the detection of postoperative deterioration: a protocol for a multistage, multicentre, international, prospective cohort study. [PDF]

BMJ Open
Jiwa A, Cameron MM, Ademuyiwa AO, Adisa A, Aguilera Arévalo ML, Bahrami Hessari M, Bhangu A, Brennan PM, Clark N, Cresswell K, Czerwinska I, D'Adderio L, Gunn E, Haque PD, Ikegwuonu T, Lawani I, Morton D, Nganwa A, Ntirenganya F, Pius R, Ramos de la Medina A, Samuel S, Shaw CA, Tabiri S, Townsend RC, Varghese C, Ghosh D, Harrison EM, NIHR Global Health Research Unit on Global Surgery.   +28 more
europepmc   +1 more source

Clinical Pharmacology Quality Assurance Program for Global HIV and Co‐Infection Drug Development

Clinical Pharmacology &Therapeutics, EarlyView.
When the acquired immunodeficiency syndrome emerged in the 1980s, the United States National Institutes of Health established research networks to conduct clinical trials with the pharmaceutical industry to identify effective antiretroviral therapeutics.
Robin DiFrancesco, Troy D. Wood, Raymond Cha, Jill S. Hochreiter, Susan L. Rosenkranz, Mona Farhad, Kyle R. Whitson, Connor E. Gould, Lauren E. Hill, Linda L. Hale, Philip H. Lindhorst, Diala Ghazal, Charlene R. Taylor, Madiha Quraishi, Suzanne M. Siminski, Yoninah Cramer, Heather L. Sprenger, Gene D. Morse   +17 more
wiley   +1 more source

Advancing Pharmacometrics in Africa: Insights and Perspectives From the 2025 Pharmacometrics Africa Conference

Clinical Pharmacology &Therapeutics, EarlyView.
Pharmacometrics (PMX) in Africa has transitioned from foundational capacity‐building to job creation, scientific leadership, regulatory influence, and health innovation. To accelerate this progress, the 2025 Pharmacometrics Africa Conference (PMXAC‐2025) convened key stakeholders to consolidate the continental PMX community, review progress in local ...
Babatunde Ayodeji Adeagbo, Innocent Gerald Asiimwe, Linda Chaba, Aida N. Kawuma, Francis Williams Ojara, Ochuko Maureen Orherhe, Simon Peter Asiimwe, Veshni Pillay‐Fuentes Lorente, Sharon Sawe, Cassius M. Phogole, Catriona Waitt, Samer Mouksassi, Goonaseelan (Colin) Pillai   +12 more
wiley   +1 more source

Comparison of drug approvals of the FDA and EMA between 2013 and 2023. [PDF]

Naunyn Schmiedebergs Arch Pharmacol
Lau F, Seifert R.
europepmc   +1 more source

Safety, Pharmacokinetics, and Dose Recommendations for Nirmatrelvir/Ritonavir in Individuals with Mild to Moderate COVID‐19 and Severe Renal Impairment

Clinical Pharmacology &Therapeutics, EarlyView.
Patients with severe renal impairment and COVID‐19 are at high risk for severe disease and death. Nirmatrelvir/ritonavir, an antiviral therapy for COVID‐19, is eliminated by renal excretion and can accumulate in patients with severe renal impairment.
Jacqueline Gerhart, Candace R. Bramson, Michelle Goulding, Haihong Shi, Olayide Oladoyinbo, Phylinda L. S. Chan, Sunring Chime, Jennifer Hammond   +7 more
wiley   +1 more source

The Psychosis MRI Shared Data Resource (Psy-ShareD). [PDF]

Hum Brain Mapp
Allen P, Zurita M, Easmin R, Bucci S, Kempton MJ, Rogers J, Mehta UM, McGuire PK, Lawrie SM, Whalley H, Gadelha A, Murray GK, Garrison JR, Frangou S, Upthegrove R, Evans SL, Kumari V, Psy‐ShareD Partnership.   +17 more
europepmc   +1 more source

Harmonisation and implementation of sports-related concussion guidelines in European youth football: the REFORM Erasmus+ project. [PDF]

BMJ Open Sport Exerc Med
Gorgoni G, Monthuley G, Andersen TE, Kümmeth-Gangel N, Pavlinac Dodig I, Dinç D, Meyer T, Nordström A.   +7 more
europepmc   +1 more source