Results 31 to 40 of about 5,946 (190)

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

A Blockchain-Based Post-Marketing Surveillance System for Medical Devices [PDF]

مجله علوم پزشکی صدرا
Nowadays, medical devices are widely used around the world. In every country, the safety of these devices is inextricably related to public health and security.
Ali Tavakoli Golpaygani, Fereshteh-Azadi Parand, Mohammad Amin Keshavarz   +2 more
doaj   +1 more source

Antipsychotics and Torsadogenic Risk: Signals Emerging from the US FDA Adverse Event Reporting System Database [PDF]

, 2013
Background: Drug-induced torsades de pointes (TdP) and related clinical entities represent a current regulatory and clinical burden. Objective: As part of the FP7 ARITMO (Arrhythmogenic Potential of Drugs) project, we explored the publicly available US ...
A Bate, A Clarke, A Pariente, AK Chung, Ariola Koci, B Darpo, BJ Drew, C Meyer-Massetti, DM Roden, DW Hough, E Poluzzi, E Poluzzi, E Poluzzi, E Raschi, E Raschi, Edoardo Spina, Elijah R. Behr, Elisabetta Poluzzi, Emanuel Raschi, EP Puijenbroek van, ER Behr, F Ponti De, F Ponti De, F Rani, Fabrizio De Ponti, GC Alexander, GK Isbister, H Verdoux, J Nielsen, J Papay, K Jolly, K Titier, LC Wittkampf, LS Schneider, Miriam Sturkenboom, NP Tatonetti, P Kannankeril, P Manu, P Vigneault, RC Owens Jr, RR Shah, S Dhillon, S Hennessy, S Kongsamut, S Leucht, SM Straus, Ugo Moretti, W Crumb, W Crumb, WA Ray, WA Ray, WJ Crumb Jr, WP Stephenson, Y Suzuki   +53 more
core   +4 more sources

Occurrence of Pulmonary Oil Microembolism After Testosterone Undecanoate Injection: A Postmarketing Safety Analysis

Sexual Medicine, 2020
Background: The Aveed Risk Evaluation and Mitigation Strategy program was instituted because of potential risk of pulmonary oil microembolism (POME) and/or anaphylaxis after intramuscular injection of Aveed (testosterone undecanoate), indicated for ...
Alexander W. Pastuszak, MD, PhD, Yiqun Hu, MD, PhD, Jeffrey D. Freid, MD   +2 more
doaj   +1 more source

Postlicensure safety surveillance of congenital anomaly and miscarriage among pregnancies exposed to quadrivalent human papillomavirus vaccine

Human Vaccines & Immunotherapeutics, 2018
Limited safety data are available on inadvertent exposure to quadrivalent human papillomavirus vaccine (4vHPV) during pregnancy. We conducted a descriptive observational postlicensure safety surveillance study in Kaiser Permanente Southern California and
Lina S. Sy, Kristin I. Meyer, Nicola P. Klein, Chun Chao, Christine Velicer, T. Craig Cheetham, Bradley K. Ackerson, Jeff M. Slezak, Harpreet S. Takhar, John Hansen, Kamala Deosaransingh, Kai-Li Liaw, Steven J. Jacobsen   +12 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

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

Post-Marketing Surveillance of a generic Oxaliplatin (AlvoxalⓇ) in Iranian Patients with Cancer

Current Therapeutic Research, 2022
: Background: CRC is the second and third most common cancer in women and men, respectively. The national comprehensive cancer network guidelines recommend oxaliplatin-based chemotherapy as a preferred regimen for patients with advanced or metastatic ...
Farhad Shahi, Mojtaba Gorji, Assistant Professor of Pediatric Oncology, Mehrdad Payandeh, Assistant Professor of Hematology & Oncology, Hamid Rezvani, Associate Professor of Hematology & Oncology, Mohammad Vaezi, Associate Professor of Hematology & Oncology, Sharareh Seifi, Assistant Professor of Hematology & Oncology, Alireza Baari, Post doctoral fellowship, Reza Khalili-Dizaji, Post doctoral fellowship, Seyed Mehdi Hashemi, Associate Professor of Hematology & Oncology, Saeid Salimi, post doctoral fellowship, Hosein Kamranzadeh, Associate Professor of Hematology & Oncology, Babak Shazad, Post doctoral fellowship, Sina Salari, Associate Professor of Hematology & Oncology, Davoud Oulad Dameshghi, Assistant Professor of Hematology & Oncology, Mehdi Sarkheil, Post doctoral fellowship, Mehrzad Mirzania, Associate Professor of Hematology & Oncology, Nassim Anjidani, Pharm. D.   +16 more
doaj   +1 more source

Actions to mitigate ocular adverse events related to hair styling cosmetics in Brazil: a descriptive and correlational study (2022-2024) [PDF]

Epidemiologia e Serviços de Saúde
Objective To describe health surveillance actions implemented by the Brazilian Health Regulatory Agency (ANVISA) to mitigate cases of ocular adverse events related to hair styling creams in Brazil and verify correlation between reported cases and these ...
Daniel Marques Mota, Leonardo Oliveira Leitão, Ronald Santos Silva, Cássia de Fátima Rangel Fernandes, Marcus Tolentino Silva   +4 more
doaj   +1 more source

Comparison of rates of nausea side effects for prescription medications from an online patient community versus medication labels: an exploratory analysis

AAPS Open, 2017
Background While medication labels are considered the authoritative resource for medication information, emerging research suggests that patient-generated health data (PGHD) are a valuable tool to understand the ways in which patients experience ...
David A. Blaser, Stephanie Eaneff, James Loudon-Griffiths, Stephanie Roberts, Paulina Phan, Paul Wicks, James Weatherall   +6 more
doaj   +1 more source