Results 141 to 150 of about 4,520,848 (313)

Serious Infection in Crohn's Disease Patients Treated With Ustekinumab: US Food and Drug Administration Active Postmarket Risk Identification and Analysis in the Sentinel Initiative

Clinical Pharmacology &Therapeutics, EarlyView.
The U.S. Food and Drug Administration (FDA) used an Active Postmarket Risk Identification and Analysis (ARIA) system to address a safety issue (serious infection) identified during clinical review of an application to market ustekinumab as a treatment for Crohn's disease (CD). FDA used an active‐comparator new‐user cohort design, data from six Sentinel
Joel L. Weissfeld, Geetha S. Iyer, Suna C. Seo, Andrew Giffin, Andrew L. Simon, Sheryl A. Kluberg, Emma R. Hoffman, Jamal T. Jones, Sarah K. Dutcher, Joyce A. Korvick   +9 more
wiley   +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

Sex-Specific Factors Influencing HIV Infection. [PDF]

Immunol Rev
Pujantell M, Altfeld M.
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

HIV infection is independently associated with carotid plaque burden and echogenic characteristics. [PDF]

Open Heart
Li X, Liu L, Chen J, Cao J, Wang Z, Qi T, Sun J, Yang J, Xu S, Song W, Shao Y, Chen Y, Tang Y, Wang J, Wang L, Huang J, Wang K, Sun M, Jin Y, Zeng Z, Zhao Z, Zhang R, Ding Y, Shen Y.   +23 more
europepmc   +1 more source

Diagnosing HIV infection [PDF]

Clinical Medicine, 2003
openaire   +2 more sources

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

Optimal Dose and Safety of Intravenous Favipiravir in Hospitalized Patients With COVID‐19: A Dose‐Escalating, Randomized Controlled Phase Ib Study

Clinical Pharmacology &Therapeutics, EarlyView.
AGILE (NCT04746183) is a Phase Ib/IIa platform, evaluating candidates to treat COVID‐19. Candidate Specific Trial 6 evaluated the safety and optimal dose of a novel intravenous formulation of favipiravir in a dose‐escalating, open‐label, randomized, controlled, Bayesian adaptive Phase Ib trial.
Tim Rowland, Richard FitzGerald, Elizabeth Challenger, Laura Dickinson, Laura J. Else, Lauren Walker, Colin Hale, Victoria Shaw, Callum Kelly, Rebecca Lyon, Jennifer Gibney, Karim Dhamani, Margaret Irwin, Yvanne Enever, Michelle Tetlow, William Wood, Helen Reynolds, Justin Chiong, Orod Osanlou, Henry Pertinez, Katie Bullock, William Greenhalf, Andrew Owen, David G. Lalloo, Michael Jacobs, Julian A. Hiscox, Thomas Jaki, Pavel Mozgunov, Geoffrey Saunders, Gareth Griffiths, Saye H. Khoo, Thomas E. Fletcher, on behalf of the AGILE CST‐6 Study Group, Shazaad Ahmad, Christopher J. Edwards, Lesley Dry, Georgie McKenzie, Aleksandra Ros, Michael Stackpoole, Laura Bradley, Karen Jennings‐Wilding, Nicholas Paton, Fred Hayden, Janet Darbyshire, Amy Lucas, Ulrika Lorch, Andrew Freedman, Richard Knight, Steven Julious   +48 more
wiley   +1 more source

Enterocyte Autoantibodies (GECAs) and HLA: Their Relationship with HIV Infection Pathogenesis. [PDF]

Int J Mol Sci
Arnaiz-Villena A, Lledo T, Vaquero-Yuste C, Juarez I, Martin-Villa JM.   +4 more
europepmc   +1 more source