Results 11 to 20 of about 13,126 (223)

Postmarketing safety of orphan drugs: a longitudinal analysis of the US Food and Drug Administration database between 1999 and 2018 [PDF]

Orphanet Journal of Rare Diseases, 2022
Background Information about the specific regulatory environment of orphan drugs is scarce and inconsistent. Uncertainties surrounding the postmarketing long-term safety of orphan drugs remain. This study aimed to evaluate the labelling changes of orphan
Min Fan, Adrienne Y. L. Chan, Vincent K. C. Yan, Xinning Tong, Lauren K. W. Lau, Eric Y. F. Wan, Eliza Y. T. Tam, Patrick Ip, Terry Y. Lum, Ian C. K. Wong, X. Li   +10 more
doaj   +2 more sources

Safety of Brexanolone in Adults with Postpartum Depression: Postmarketing Surveillance Data

Drugs - Real World Outcomes, 2023
Background Brexanolone is currently the only medication approved by the US FDA for the treatment of postpartum depression (PPD) in patients ≥15 years. Brexanolone is available commercially only through a restricted program (ZULRESSO® Risk Evaluation and ...
Svetlana Garafola, Elizabeth Shiferaw, Vikram Dev   +2 more
doaj   +2 more sources

Overview of the Premarketing and Postmarketing Requirements for Drugs Granted Japanese Conditional Marketing Approval

Clinical and Translational Science, 2021
For drugs that are intended to fill unmet medical needs, such as the treatment of rare diseases or a subtype of cancer, it can take a long time to conduct confirmatory clinical trials due to limited patient availability.
Shunsuke Matsushita, Keisuke Tachibana, Tetsuya Kusakabe, Ryuichi Hirayama, Yasuo Tsutsumi, Masuo Kondoh   +5 more
doaj   +2 more sources

Postmarketing Studies: Benefits and Risks

Value in Health, 1999
To consider the benefits and risks of large postmarketing outcomes studies, as demonstrated by studies of the statin drugs.Literature review.The risks were that the statin studies had a strong coat-tail effect. Each new study was beneficial to all statins as well as the one studied.
Garfield, Frances B., Caro, J. Jaime
openaire   +3 more sources

Dalfampridine extended release tablets: 1 year of postmarketing safety experience in the US

Neuropsychiatric Disease and Treatment, 2013
Michele Jara,1 Graham Barker,2 Herbert R Henney 3rd1 1Acorda Therapeutics, Inc, Ardsley, NY, USA; 2Biogen Idec, Inc, Maidenhead, Berkshire, UK Background: Dalfampridine extended release tablets (dalfampridine-ER; prolonged-, modified, or sustained ...
Jara M, Barker G, Henney 3rd HR
doaj   +1 more source

Postmarketing surveillance [PDF]

BMJ, 1994
S, Voss, F, Harris
openaire   +3 more sources

Postmarketing safety experience with edoxaban in Japan for thromboprophylaxis following major orthopedic surgery

Vascular Health and Risk Management, 2013
Yasufumi Kuroda,1 Chie Hirayama,2 Hitoshi Hotoda,2 Yasuhiro Nishikawa,2 Akinori Nishiwaki21Daiichi Sankyo Pharma Development, Edison, NJ, USA; 2Daiichi Sankyo Company, Limited, Tokyo, JapanPurpose: Edoxaban is an oral, once-daily, selective, direct ...
Kuroda Y, Hirayama C, Hotoda H, Nishikawa Y, Nishiwaki A   +4 more
doaj   +1 more source

In vitro and in vivo postmarketing surveillance of valsartan, alone or in combination with amlodipine or hydrochlorthiazide, among Palestinian hypertensive patients

Therapeutics and Clinical Risk Management, 2016
Abdel Naser Zaid,1 Masshour Ghanem,2 Dua’a Shweiki,1 Hala Shtewi,1 Raja’ Shaheen,1 Sondos Al Helaly,1 Zeina Khayyat,1 Rowa’a Al Ramahi,1 Sa’ed H Zyoud1 1Department of Pharmacy, Faculty of Medicine & Health Sciences, An-Najah ...
Zaid AN, Ghanem M, Shweiki D, Shtewi H, Shaheen R, Al Helaly S, Khayyat Z, Al Ramahi R, Zyoud SH   +8 more
doaj   +1 more source

First‐Line Osimertinib in Patients with EGFR‐Mutant Advanced Non‐Small Cell Lung Cancer: Outcome and Safety in the Real World: FLOWER Study

The Oncologist, EarlyView., 2021
Abstract Lessons Learned Osimertinib has confirmed effectiveness in this real‐world population of patients with EGFR‐mutant advanced non‐small cell lung cancer. Thromboembolic events occur more frequently than previously reported, suggesting a thrombotic diathesis that requires further investigation. Patients with at least three metastatic sites, brain
Martina Lorenzi, Alessandra Ferro, Fabiana Cecere, Daniela Scattolin, Alessandro Del Conte, Alessandro Follador, Sara Pilotto, Valentina Polo, Mariacarmela Santarpia, Rita Chiari, Alberto Pavan, Alessandro Dal Maso, Valentina Da Ros, Giada Targato, Sabrina Vari, Stefano Indraccolo, Fiorella Calabrese, Stefano Frega, Laura Bonanno, Pier Franco Conte, Valentina Guarneri, Giulia Pasello   +21 more
wiley   +1 more source

Enhancing Postmarketing Surveillance Systems for Improved Pharmacovigilance [PDF]

, 2023
Postmarketing surveillance systems play a critical role in monitoring the safety and effectiveness of drugs in real-world settings. However, there is a growing need to enhance these systems to ensure early detection and effective management of adverse ...
Muhammad Aoun, Suresh Budha Dahal
core   +1 more source