Results 21 to 30 of about 21,353 (254)

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

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

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

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

Trends and characteristics of accidental and intentional codeine overdose deaths in Australia [PDF]

, 2015
Examines trends in codeine-related mortality rates in Australia, and the clinical and toxicological characteristics of codeine-related deaths. Abstract Objectives: To examine trends in codeine-related mortality rates in Australia, and the clinical and ...
Amanda Roxburgh, Eva Saar, Jennifer Pilgrim, Louisa Degenhardt, Lucinda Burns, Suzanne Nielsen, Wayne D Hall   +6 more
core   +1 more source

Improving the external validity of clinical trials: the case of multiple chronic conditions [PDF]

, 2013
The U.S. Department of Health and Human Services vision and strategic framework on multiple chronic conditions (MCCs) incorporates recommendations designed to facilitate research that will improve our knowledge about interventions and systems that will ...
Fortin, Martin, Smith, Susan M.
core   +4 more sources

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

Neonatal Safety Information Reported to the FDA During Drug Development Studies. [PDF]

, 2018
BACKGROUND: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates
Ariagno, Ron, Avant, Debbie, Baer, Gerri, Burckart, Gilbert J., Moore, Jason N., Sorbello, Alfred, Wang, Jian, Yao, Lynne, Zheng, Panli   +8 more
core   +3 more sources

Physicians' Experiences as Patients with Statin Side Effects: A Case Series. [PDF]

, 2017
Physicians are among those prescribed statins and therefore, subject to potential statin adverse effects (AEs). There is little information on the impact of statin AEs on physicians affected by them. We sought to assess the character and impact of statin
Golomb, Beatrice Alexandra, Koslik, Hayley J, Meskimen, Athena Hathaway   +2 more
core   +2 more sources