Results 81 to 90 of about 21,353 (254)

Comparison of Data Mining Methods for the Signal Detection of Adverse Drug Events with a Hierarchical Structure in Postmarketing Surveillance [PDF]

, 2020
Goeun Park, Heesun Jung, Seok‐Jae Heo, Inkyung Jung   +3 more
openalex   +1 more source

Is the Safety of Finasteride Correlated With Its Route of Administration: Topical Versus Oral? A Pharmacovigilance Study With Data From the United States Food and Drug Administration Adverse Event Reporting System

International Journal of Dermatology, Volume 65, Issue 1, Page 108-118, January 2026.
ABSTRACT Background The United States Food and Drug Administration (FDA) approved oral finasteride for androgenetic alopecia. In 2022, approximately 2.6 million U.S. men used it for hair loss and prostate conditions. Post‐finasteride syndrome (PFS), proposed in 2012, involves persistent sexual and neuropsychiatric adverse events (AEs) after cessation ...
Aditya K. Gupta, Mesbah Talukder, Sharon A. Keene, Mary A. Bamimore   +3 more
wiley   +1 more source

Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence

BMJ Open
Objectives To compare the premarket and postmarket evidence of safety and efficacy of direct oral anticoagulants approved for stroke prevention in atrial fibrillation patients across four major regulatory agencies.Design Cross-sectional.Setting European ...
Joseph S Ross, Tianna Zhou, Maryam Mooghali   +2 more
doaj   +1 more source

EDDA Study Designs Taxonomy (version 2.0) [PDF]

, 2016
The EDDA Study Designs Taxonomy (v2.0) was developed by the Evidence in Documents, Discovery, and Analytics (EDDA) Group: Tanja Bekhuis (Principal Scientist); Eugene Tseytlin (Systems Developer); Ashleigh Faith (Taxonomist); Faina Linkov (Epidemiologist).
Bekhuis, Tanja, Tseytlin, Eugene
core   +1 more source

Global Recommendations for Facial Rejuvenation Using a Hyaluronic Acid and Calcium Hydroxyapatite Hybrid Injectable

Journal of Cosmetic Dermatology, Volume 25, Issue 1, January 2026.
ABSTRACT Background The hybrid injectable HA‐CaHA contains a formulated matrix of crosslinked hyaluronic acid (HA) gel with embedded calcium hydroxyapatite (CaHA) microspheres to increase skin elasticity and hydration as well as promote neocollagenesis, respectively. Clinical practice recommendations for use of HA‐CaHA are limited.
Maurizio Cavallini, Andre Braz, Daniela Greiner‐Krüger, Sylwia Lipko‐Godlewska, Tapan Patel, Marva Safa, Sophie Shotter, Fernando Urdiales Gálvez, Graeme Kerson   +8 more
wiley   +1 more source

Therapeutics for Rheumatoid Arthritis: A Phase 4 Clinical Trial Analysis With a Focus on Disability Outcomes

Journal of Clinical Pharmacy and Therapeutics, Volume 2026, Issue 1, 2026.
Background Rheumatoid arthritis (RA) is a chronic autoimmune disease marked by persistent synovitis, cartilage damage, progressive disability, and a significant decline in quality of life. The advent of biologics and small molecule inhibitors has substantially improved disease management and reduced disability.
Nasser M. Alorfi, Fahad S. Alshehri, Ahmed M. Ashour, Mohammed M. Aldurdunji, Mustfa Faisal Alkhanani, Reem Hasaballah Alhasani, Mohammed S. Alharthi, Nasser M. Aldekhail, Anjali Chauhan   +8 more
wiley   +1 more source

Post-marketing stability surveillance: Amoxicillin

South African Family Practice, 2006
Background: To ensure the successful treatment of infectious disease using antimicrobial therapy, a sufficient concentration of the stable, active drug is required at the site of infection.
K.K. Naidoo, P. Nompuku, S.N. Mkalali, K. Shabangu, L. Nkabinde, V. Singh   +5 more
doaj   +1 more source

Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety

Patient Preference and Adherence
Carlos De las Cuevas,1 Emilio J Sanz,2,3 Jose de Leon4,5 1Department of Internal Medicine, Dermatology, and Psychiatry and Instituto Universitario de Neurociencia (IUNE), Universidad de La Laguna, La Laguna, Canary Islands, Spain; 2Department of Physical
De las Cuevas C, Sanz EJ, de Leon J
doaj  

Postmarketing surveillance [PDF]

BMJ, 1994
S, Voss, F, Harris
openaire   +2 more sources

No Humans Have Been Injured in the Testing of this Drug: The New Animal Efficacy Rule [PDF]

, 2012
This paper examines the “Animal Efficacy Rule,†a regulation that provides for the approval of products by the FDA when efficacy testing on humans is ethically impossible.
Campbell, Carrie
core