Results 81 to 90 of about 10,049 (144)

Zofenopril and incidence of cough: a review of published and unpublished data

Therapeutics and Clinical Risk Management, 2011
Stefano Omboni1, Claudio Borghi21Italian Institute of Telemedicine, Varese, Italy; 2Department of Internal Medicine, Aging, and Kidney Diseases, University Hospital of Bologna, Bologna, ItalyObjective: Cough is a typical side effect of angiotensin ...
Omboni S, Borghi C
doaj  

Regulatory approval, reimbursement and postmarketing evidence of class 1 novel drugs in China, 2018–2023: an observational study

BMJ Public Health
Introduction The global pharmaceutical industry is undergoing profound changes, with countries worldwide actively investing in innovation ecosystems. In China, innovation has been incentivised through policies aimed at regulatory modernisation, value ...
Xin Gao, Rui Li, Thomas Butt, Liang Yao, Feng Xie, Xue Li, Kun Zhao, Monica Yu, Yao-Ling Wang, Xiao-Lu Zhang, Pei-Meng Wang, Fei-Yi Xiao, Yi-sha Lin, Xue-fei Gu, Yu-zheng Zhang, Wu-Dong Guo   +15 more
doaj   +1 more source

Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020.

JAMA Netw Open, 2021
Moneer O, Lee CC, Avorn J, Kesselheim AS.   +3 more
europepmc   +1 more source

Reporting of Study Participant Demographic Characteristics and Demographic Representation in Premarketing and Postmarketing Studies of Novel Cancer Therapeutics.

JAMA Netw Open, 2021
Varma T, Wallach JD, Miller JE, Schnabel D, Skydel JJ, Zhang AD, Dinan MA, Ross JS, Gross CP.   +8 more
europepmc   +1 more source

Diversity in Translation: Equal Is Greater Than

Clinical and Translational Science, Volume 19, Issue 9, September 2026.
Elvin T. Price, John A. Wagner
wiley   +1 more source

Drug Utilization Studies in Pregnant Women for Newly Licensed Medicinal Products: A Contribution from IMI ConcePTION

Journal of Pregnancy
Purpose. Studies focusing on safety outcomes typically require large populations to comprehensively characterise the patient groups exposed to the medicines under investigation.
Sandra Lopez-Leon, Anja Geldhof, Julie Scotto, Keele Wurst, Meritxell Sabidó, Jingping Mo, Ditte Molgaard-Nielsen, Jorieke E. H. Bergman, Xuan Anh Phi, Sue Jordan   +9 more
doaj   +1 more source

Safety of COVID-19 mRNA-1273 booster doses in Asian populations: A literature review of post-marketing observational studies

Human Vaccines & Immunotherapeutics
Real-world data on the safety of COVID-19 booster doses in Asian populations are needed to inform national immunization programs. The safety profile of mRNA-1273 (Moderna, Inc.) was evaluated using post-marketing observational data.
Chris Clarke, Daina Esposito, Veronica Urdaneta, Piyali Mukherjee, Amanda K. Buttery   +4 more
doaj   +1 more source

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study. [PDF]

BMJ Open, 2017
Zeitoun JD, Ross JS, Atal I, Vivot A, Downing NS, Baron G, Ravaud P.   +6 more
europepmc   +1 more source

Completion and outcomes of postmarketing requirements and commitments issued by the US Food and Drug Administration for new drugs, 2016-24: cross sectional evaluation of postmarketing studies. [PDF]

BMJ Med
Siebert M, McGonigle R, Gutiérrez-Sacristán A, Naci H, Wagner AK, Bourgeois FT.   +5 more
europepmc   +1 more source

Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act.

JAMA Pediatr, 2019
Hwang TJ, Orenstein L, Kesselheim AS, Bourgeois FT.   +3 more
europepmc   +1 more source