Results 11 to 20 of about 19,507 (228)

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

Evidence and Extrapolation: Mechanisms for Regulating Off-Label Uses of Drugs and Devices [PDF]

, 2014
A recurring, foundational issue for evidence-based regulation is deciding whether to extend governmental approval from an existing use with sufficient current evidence of safety and efficacy to a novel use for which such evidence is currently lacking ...
Abbott, Ryan, Ayres, Ian
core   +3 more sources

Pneumococcal serotypes in children in 4 European countries [PDF]

, 2010
After heptavalent pneumococcal conjugate vaccine (PCV7) was marketed in France, Spain, Belgium, and England and Wales (United Kingdom), invasive disease from non-PCV7 serotypes (NVT) increased. Adjusted serotype-specific incidences among children
Fenoll, Asuncion, George, Robert, Hanquet, Germaine, Kissling, Esther, Lepoutre, Agnes, Lernout, Tinne, Tarrago, David, Varon, Emmanuelle, Verhaegen, Jan   +8 more
core   +3 more sources

The experience of accommodating privacy restrictions during implementation of a large-scale surveillance study of an osteoporosis medication. [PDF]

, 2016
PurposeTo explore whether privacy restrictions developed to protect patients have complicated research within a 15-year surveillance study conducted with US cancer registries.MethodsData from enrolling 27 cancer registries over a 10-year period were ...
Andrews, Elizabeth B, Deapen, Dennis M, Gilsenan, Alicia W, Harris, David H, Hornicek, Francis J, Midkiff, Kirk D, Schymura, Maria J   +6 more
core   +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

Safety profile of oxcarbazepine: results from a prescription-event monitoring study [PDF]

, 2010
Purpose: To monitor safety of oxcarbazepine, prescribed in primary care in England, using prescription-event monitoring (PEM). Methods: Postmarketing surveillance using observational cohort technique of PEM.
Buggy, Y., Fogg, Carole, Layton, D., Shakir, S.   +3 more
core   +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

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

Edoxaban: an update on the new oral direct factor Xa inhibitor. [PDF]

, 2014
Edoxaban is a once-daily oral anticoagulant that rapidly and selectively inhibits factor Xa in a concentration-dependent manner. This review describes the extensive clinical development program of edoxaban, including phase III studies in patients with ...
A. John Camm, AC Skanes, AG Turpie, AJ Camm, AK Kakkar, AT Cohen, B Laulicht, BF Gage, BI Eriksson, BI Eriksson, BI Eriksson, BI Eriksson, BS Stambler, C Kearon, CB Granger, CT Ruff, DE Salazar, G Agnelli, G Agnelli, G Lu, G Raskob, G Raskob, H Masumoto, H Zahir, Henri Bounameaux, J Mendell, J Mendell, J Mendell, J Mendell, J Mendell, J Mendell, J Stampfuss, JH Alexander, JI Weitz, JL Mega, K Ogata, KL Furie, LT Grip, M Crowther, M Hori, M Pirmohamed, MR Lassen, MR Lassen, MR Lassen, MR Lassen, MR Patel, MS Bathala, MU Zafar, N Chung, N Matsushima, R Caterina De, R Caterina De, RP Giugliano, S Kaatz, S Schulman, S Schulman, S Schulman, SE Kimmel, SJ Connolly, SJ Connolly, SJ Connolly, SZ Goldhaber, T Fuji, T Fuji, T Fukuda, T Hulle van der, T Mikkaichi, T Wilke, T Yamashita, TI Verhoef, W Mueck, Y Falck-Ytter, Y Kuroda   +72 more
core   +1 more source