Results 21 to 30 of about 6,029 (168)
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 +8 more
core +3 more sources
Therapeutic Advances in Drug Safety, 2019 Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product.
Nikhil Raj +5 more
doaj +1 more source
Development, Production, and Postmarketing Surveillance of Hepatitis A Vaccines in China
Journal of Epidemiology, 2014 China has long experience using live attenuated and inactivated vaccines against hepatitis A virus (HAV) infection. We summarize this experience and provide recent data on adverse events after immunization (AEFIs) with hepatitis A vaccines in China.
Cui, Fuqiang +5 more
openaire +3 more sources
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 +6 more
core +1 more source
Journal of Diabetes Investigation, 2019 Aims/Introduction Specified Drug Use Results Survey of Ipragliflozin Treatment in Type 2 Diabetic Patients: Long‐term Use is an ongoing postmarketing study of ipragliflozin for long‐term use in Japanese patients with type 2 diabetes mellitus.
Kazuyuki Tobe +4 more
doaj +1 more source
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 +6 more
core +1 more source
A Blockchain-Based Post-Marketing Surveillance System for Medical Devices [PDF]
مجله علوم پزشکی صدراNowadays, 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 +2 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
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 +12 more
doaj +1 more source
Safety of opioid patch initiation in Australian residential aged care [PDF]
, 2015 Explores opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Abstract Objective: To explore opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Design:
Elizabeth Roughead +2 more
core +1 more source