Results 11 to 20 of about 25,533 (219)

Postmarketing surveillance study of a non-chlorofluorocarbon inhaler [PDF]

BMJ, 1999
Editor—The study by Ayres et al may have been selectively designed to promote a product as safe; they endorse it as conforming to unpublished guidelines for postmarketing surveillance studies under safety assessment of marketed medicines.1 Withdrawals from the study are mainly for reasons “not related to safety,” and the withdrawal rate of the product ...
M G Bamber, C. Paterson, J G Ayres, C D Frost, W F Holmes, D R R Williams, S M Ward   +6 more
openaire   +4 more sources

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada

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, Swapnil Fernandes, Narayana R. Charyulu, Akhilesh Dubey, Ravi G. S., Srinivas Hebbar   +5 more
doaj   +2 more sources

Effectiveness and Safety of Guselkumab in Patients With Moderate‐to‐Severe Plaque Psoriasis in Real‐World Practice in Korea: A Prospective, Multicenter, Observational, Postmarketing Surveillance Study

The Journal of Dermatology, EarlyView.
ABSTRACT Clinical trials have demonstrated the efficacy and safety of guselkumab in patients with moderate‐to‐severe plaque psoriasis. Real‐world evidence for guselkumab in Korea is needed to establish drug safety and effectiveness under real‐world practice in this population.
Bong Seok Shin, Miri Kim, Moo Kyu Suh, Young Bok Lee, Sang Woong Youn, Ji Yeoun Lee, Chul Woo Kim, Ga‐Young Lee, Sang Wook Son, Kwang Ho Kim, Jihye An, Youngdoe Kim, Kwang Joong Kim, Dong Hyun Kim   +13 more
wiley   +2 more sources

Minimal dataset for post‐registration surveillance of new drugs in hemophilia: communication from the SSC of the ISTH [PDF]

Journal of Thrombosis and Haemostasis, 2017
Clinical ...
F. Peyvandi, M. Makris, Peter Collins, D. Lillicrap, S. Pipe, Alfonso Iorio, F. R. Rosendaal   +6 more
semanticscholar   +5 more sources

Characteristics of safety information obtained from postmarketing observational studies for re-examination in Japan [PDF]

SpringerPlus, 2016
BackgroundIn Japan, postmarketing surveillance (PMS) studies are required for newly approved drug products to further collect safety information in clinical settings.
Tatsuya Watanabe, M. Narukawa
semanticscholar   +3 more sources

Endovascular Aneurysm Repair Devices as a Use Case for Postmarketing Surveillance of Medical Devices.

JAMA Intern Med, 2023
Importance The US Food and Drug Administration (FDA) is building a national postmarketing surveillance system for medical devices, moving to a "total product life cycle" approach whereby more limited premarketing data are balanced with postmarketing ...
Wang X, Ayakulangara Panickan V, Cai T, Xiong X, Cho K, Cai T, Bourgeois FT.   +6 more
europepmc   +2 more sources

Severe Gastrointestinal Toxicity Following the Use of Gilteritinib: A Case Series and Analysis of Postmarketing Surveillance Data

Healthcare, 2023
Gilteritinib has been approved as monotherapy in adults with acute myeloid leukemia (AML) FLT3 mutated with relapsed or refractory disease, in light of its advantages in terms of survival and the favorable safety profile.
L. Gozzo, A. Nardo, Serena B. Brancati, Antongiulio Judica, A. Duminuco, C. Maugeri, M. Parisi, L. Longo, D. Vitale, Rosy Ruscica, G. L. Romano, E. Mauro, P. Fiumara, G. Palumbo, F. Di Raimondo, C. Vetro, F. Drago   +16 more
semanticscholar   +1 more source

Postmarketing assessment of a switchable similar anastrozole product in Brazilian breast cancer patients

Brazilian Journal of Oncology, 2022
Several formulations of the aromatase inhibitor anastrozole are available in Brazil. We carried out a postmarketing surveillance of the anastrozole (test) formulation in current use at the Brazilian National Cancer Institute (INCA), by comparing ...
Manuela Vasquez Cardoso, R. Obadia, Luna Silva, Priscila Pentagna, R. Linden, V. C. Fernandes, A. C. de Melo, G. Suarez-Kurtz   +7 more
semanticscholar   +1 more source

Real-World Use of Generic Meropenem: Results of an Observational Study

Antibiotics, 2021
Background: To determine the therapeutic effect and tolerability of meropenem in routine clinical practice, in terms of clinical and microbiological response.
Santiago Garnica-Velandia, Luz Adriana Aristizábal-Ruiz, Carlos Arturo Alvarez-Moreno   +2 more
doaj   +1 more source

Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia

Archives of medical science : AMS, 2021
Introduction In the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high ...
M. Banach, N. Katsiki, G. Latkovskis, M. Rizzo, D. Pella, Peter E. Penson, Ž. Reiner, A. Cicero   +7 more
semanticscholar   +1 more source