Results 21 to 30 of about 11,239 (184)

Use of National Database of Health Insurance Claims and Specific Health Checkups for examining practical utilization and safety signal of a drug to support regulatory assessment on postmarketing drug safety in Japan

Frontiers in Medicine, 2023
The Pharmaceuticals and Medical Devices Agency (PMDA) has conducted many pharmacoepidemiological studies for postmarketing drug safety assessments based on real-world data from medical information databases.
Haruka Shida, Kazuhiro Kajiyama, Sono Sawada, Chieko Ishiguro, Mikiko Kubo, Ryota Kimura, Mai Hirano, Noriyuki Komiyama, Toyotaka Iguchi, Yukio Oniyama, Yoshiaki Uyama   +10 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

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

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   +1 more source

Materiovigilance: An Indian perspective

Perspectives in Clinical Research, 2018
Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences.
Bikash Ranjan Meher
doaj   +1 more source

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   +1 more source

Drug therapeutic failures as a cause of admission to an intensive care unit at a university hospital

Journal of Research in Pharmacy Practice, 2019
Objective: Drug therapeutic failures (TFs) are included in pharmacovigilance reporting, as some authors consider them a type of adverse drug reaction.
Jair Antonio Ruiz-Garzon, Camilo Andrés Rojas-Velandia, Carlos-Alberto Calderon-Ospina   +2 more
doaj   +1 more source

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   +1 more source

Product-to-product differences in plasma concentration-time curves from recommended doses of prolonged-action preparations of theophylline

South African Family Practice, 1985
No abstract available.
R.S. Summers
doaj   +1 more source

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

BMC Medicine, 2019
Background Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation.
Joshua D. Wallach, Anita T. Luxkaranayagam, Sanket S. Dhruva, Jennifer E. Miller, Joseph S. Ross   +4 more
doaj   +1 more source

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Health Informatics Journal, 2020
Evaluation of premarketing drug safety in clinical trials is often limited, due to the relatively small sample size and short follow-up time. The data collected in the postmarketing spontaneous reporting systems such as Food and Drug Administration ...
Rui Duan, Xinyuan Zhang, Jingcheng Du, Jing Huang, Cui Tao, Yong Chen   +5 more
doaj   +1 more source