Results 31 to 40 of about 600,809 (212)

Clinical efficacy of long-acting neuraminidase inhibitor, laninamivir octanoate hydrate, in postmarketing surveillance [PDF]

, 2012
Iwaki, N., Kashiwagi, S., Shiozawa, T., Yamaguchi, F., Yamaguchi, H., Yoshida, S.   +5 more
core   +3 more sources

Clinical Characteristics and Safety Profiles of Japanese Psoriasis Patients Who Continued Apremilast Treatment for 6 and 12 Months: A Post Hoc Analysis of an Apremilast Postmarketing Surveillance Study [PDF]

J Dermatol
Mamitaro Ohtsuki, Yukari Okubo, Hidehisa Saeki, Atsuyuki Igarashi, Shinichi Imafuku, Masatoshi Abe, Kan Saito, Ryuichi Ogawa, Akimichi Morita   +8 more
openalex   +2 more sources

Assessment of adverse events for a home‐use intense pulsed light hair removal device using postmarketing surveillance

Lasers in Surgery and Medicine, 2023
Home‐use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home‐use IPL devices, however, remains a subject of interest.
Anne M. Hattersley, M. Kiernan, David Goldberg, C. Dierickx, D. Sliney, M. Haedersdal, J. Nash   +6 more
semanticscholar   +1 more source

Some Thoughts on Pharmacovigilance and Postmarketing Surveillance [PDF]

Clinical Therapeutics, 2016
Richard I. Shader
openalex   +4 more sources

Tacrolimus in Patients With Interstitial Pneumonia Associated With Polymyositis or Dermatomyositis: Interim Report of Postmarketing Surveillance in Japan

Journal of Rheumatology, 2022
Objective. The calcineurin inhibitor tacrolimus has been approved in Japan for the treatment of interstitial pneumonia (IP) in patients with polymyositis (PM) and dermatomyositis (DM).
M. Kuwana, N. Wakasugi, Toshinori Furuya, S. Uno, T. Suda   +4 more
semanticscholar   +1 more source

Postmarketing active surveillance of myocarditis and pericarditis following vaccination with COVID-19 mRNA vaccines in persons aged 12 to 39 years in Italy: A multi-database, self-controlled case series study

medRxiv, 2022
Objectives To investigate the association between SARS-CoV-2 mRNA vaccines, BNT162b2 and mRNA-1273, and myocarditis/pericarditis. Design Self-Controlled Case Series study (SCCS) using national data on COVID-19 vaccination and emergency care/hospital ...
M. Massari, Stefania Spila Alegiani, Cristina Morciano, M. Spuri, P. Marchione, P. Felicetti, V. Belleudi, F. Poggi, M. Lazzeretti, Michele Ercolanoni, Elena Clagnan, E. Bovo, G. Trifirò, U. Moretti, G. Monaco, Olivia Leoni, R. Da Cas, F. Petronzelli, L. Tartaglia, N. Mores, G. Zanoni, P. Rossi, Sarah Samez, Cristina Zappetti, A. Marra, Francesca Menniti Ippolito   +25 more
semanticscholar   +1 more source

Prospective Postmarketing Surveillance of Acute Myocardial Infarction in New Users of Saxagliptin: A Population-Based Study [PDF]

Diabetes Care, 2017
Sengwee Toh, Marsha E. Reichman, David J. Graham, Christian Hampp, Rongmei Zhang, Melissa G. Butler, Aarthi Iyer, Malcolm Rucker, Madelyn Pimentel, Jack Hamilton, Samuel Lendle, Bruce Fireman, G. Saylor, Neesha Nathwani, Susan E. Andrade, Jeffrey S. Brown, Denise M. Boudreau, Robert T. Greenlee, Marie R. Griffin, Michael A. Horberg, Nancy D. Lin, Cheryl N. McMahill‐Walraven, Vinit Nair, Pamala A. Pawloski, Marsha A. Raebel, Nandini Selvam, Connie Mah Trinacty   +26 more
openalex   +2 more sources

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

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

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