Results 81 to 90 of about 25,533 (219)

An international initiative to create a collaborative for pharmacovigilance in hospice and palliative care clinical practice [PDF]

, 2012
Background: Medication registration currently requires evidence of safety and efficacy from adequately powered phase 3 studies. Pharmacovigilance (phase 4 studies, postmarketing data, adverse drug reaction reporting) provide data on more widespread and
Abernethy, Amy Pickar, Currow, David Christopher, Doogue, Matthew, Rowett, Debra Sharon, To, Timothy H M   +4 more
core   +1 more source

AI‐Driven Applications in Clinical Pharmacology and Translational Science: Insights From the ASCPT 2024 AI Preconference

Clinical and Translational Science, Volume 18, Issue 4, April 2025.
ABSTRACT Artificial intelligence (AI) is driving innovation in clinical pharmacology and translational science with tools to advance drug development, clinical trials, and patient care. This review summarizes the key takeaways from the AI preconference at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) 2024 Annual Meeting in ...
Mohamed H. Shahin, Prashant Desai, Nadia Terranova, Yuanfang Guan, Tomáš Helikar, Sebastian Lobentanzer, Qi Liu, James Lu, Subha Madhavan, Gary Mo, Flora T. Musuamba, Jagdeep T. Podichetty, Jie Shen, Lei Xie, Mathew Wiens, Cynthia J. Musante   +15 more
wiley   +1 more source

Development of instrument to report and assess causality of adverse events related to herbal medicines

Vitae
: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment.
Patrícia de Carvalho Mastroianni, Fabiana Rossi Varallo, Marília Amaral Costa, Luis Vitor da Silva Sacramento   +3 more
doaj   +1 more source

Ten years of experience with ruxolitinib since approval for polycythemia vera: A review of clinical efficacy and safety

Cancer, Volume 131, Issue 1, 1 January 2025.
Abstract The oral Janus kinase (JAK) 1/JAK2 inhibitor ruxolitinib was approved by the US Food and Drug Administration in 2014 for treatment of patients with polycythemia vera (PV) who have an inadequate response to or intolerance of hydroxyurea (HU).
Lucia Masarova, John Mascarenhas, Raajit Rampal, Wilson Hu, Robert A. Livingston, Naveen Pemmaraju   +5 more
wiley   +1 more source

Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions.

Archives of Internal Medicine, 2005
BACKGROUND The Adverse Event Reporting System is the primary surveillance database used by the Food and Drug Administration for identifying postmarketing drug safety problems.
D. Wysowski, Lynette Swartz
semanticscholar   +1 more source

Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis

Sexual Medicine, 2020
Background: The Aveed Risk Evaluation and Mitigation Strategy program was instituted because of potential risk of pulmonary oil microembolism (POME) and/or anaphylaxis after intramuscular injection of Aveed (testosterone undecanoate), indicated for ...
Alexander W. Pastuszak, MD, PhD, Yiqun Hu, MD, PhD, Jeffrey D. Freid, MD   +2 more
doaj  

Vigilância de eventos adversos pós-vacinação e segurança de programas de imunização Vigilancia de eventos adversos post vacunación y seguridad de programas de inmunización Surveillance of adverse effects following vaccination and safety of immunization programs

Revista de Saúde Pública, 2011
O objetivo da revisão foi analisar aspectos conceituais e operacionais de sistemas de vigilância de eventos adversos pós-vacina. Foram incluídos artigos disponíveis em formato eletrônico, publicados entre 1985 e 2009, selecionados nas bases Medline ...
Eliseu Alves Waldman, Karin Regina Luhm, Sandra Aparecida Moreira Gomes Monteiro, Fabiana Ramos Martin de Freitas   +3 more
doaj   +1 more source

Post‐Market Evidence for Cancer Medicines in Regulatory and Clinical Decision‐Making: A Scoping Review

Pharmacoepidemiology and Drug Safety, Volume 34, Issue 1, January 2025.
ABSTRACT Background Cancer medicines usually have uncertain efficacy and safety profiles when they are first approved by medicines regulators because this evidence usually emerges post‐market. Little is known about the extent to which post‐market evidence is evaluated and integrated into evidence review processes in regulatory and clinical contexts ...
Eliza J. McEwin, Ashleigh Hooimeyer, Barbara J. Mintzes   +2 more
wiley   +1 more source

Improving the Postmarket Surveillance of Total Joint Arthroplasty Devices [PDF]

, 2011
Objective: To evaluate the FDA’s approval process and postmarket surveillance strategies for THR devices. Design: The FDA Center for Devices and Radiological Health (CDRH) 510k releasable database was used to document approved THR devices.
Brennan, Troyen Anthony, Liang, Matthew Heng, Mahomed, Nizar N, Sledge, Clement Blount, Syed, Khalid   +4 more
core   +1 more source

Low‐Dose Oral Minoxidil and Associated Adverse Events: Analyses of the FDA Adverse Event Reporting System (FAERS) With a Focus on Pericardial Effusions

Journal of Cosmetic Dermatology, Volume 24, Issue 1, January 2025.
ABSTRACT Background Low‐dose oral minoxidil (LDOM) is used to treat hair loss, but the literature on its safety profile is relatively sparse. Aims Using the FDA Adverse Event Reporting System (FAERS) database, we determined signals for adverse events (AEs) with LDOM use. Methods Four sets of case/noncase study disproportionality analyses were conducted
Aditya K. Gupta, Mary A. Bamimore, Husam Abdel‐Qadir, Greg Williams, Antonella Tosti, Vincent Piguet, Mesbah Talukder   +6 more
wiley   +1 more source