Results 21 to 30 of about 13,126 (223)

Product-to-product differences in plasma concentration-time curves from recommended doses of prolonged-action preparations of theophylline

South African Family Practice, 1985
No abstract available.
R.S. Summers
doaj   +1 more source

Materiovigilance: An Indian perspective

Perspectives in Clinical Research, 2018
Materiovigilance is the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices and protection of patient's health by preventing its recurrences.
Bikash Ranjan Meher
doaj   +1 more source

Postmarketing Safety Study Tool: A Web Based, Dynamic, and Interoperable System for Postmarketing Drug Surveillance Studies [PDF]

, 2015
Postmarketing drug surveillance is a crucial aspect of the clinical research activities in pharmacovigilance and pharmacoepidemiology. Successful utilization of available Electronic Health Record (EHR) data can complement and strengthen postmarketing ...
Gonul, Suat, Yuksel, Mustafa, Pacaci, Anil, Çiçekli, Fehime Nihan, Laleci Erturkmen, Gokce B., Sinaci, A. Anil, Thakrar, Bharat, Invernizzi, Paolo, Cinar, H. Alper   +8 more
core   +1 more source

Clinical Trial and Postmarketing Safety of Onasemnogene Abeparvovec Therapy

, 2022
INTRODUCTION: This is the first description of safety data for intravenous onasemnogene abeparvovec, the only approved systemically administered gene-replacement therapy for spinal muscular atrophy.
Tauscher-Wisniewski, Sitra, Reyna, Sandra P., Mendell, Jerry R., Day, John W., Finkel, Richard S., Strauss, Kevin A, Kleyn, Aaron, Chand, Deepa H., Tukov, Francis Fonyuy, Mercuri, Eugenio   +9 more
core   +1 more source

Drug therapeutic failures as a cause of admission to an intensive care unit at a university hospital

Journal of Research in Pharmacy Practice, 2019
Objective: Drug therapeutic failures (TFs) are included in pharmacovigilance reporting, as some authors consider them a type of adverse drug reaction.
Jair Antonio Ruiz-Garzon, Camilo Andrés Rojas-Velandia, Carlos-Alberto Calderon-Ospina   +2 more
doaj   +1 more source

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis

BMC Medicine, 2019
Background Postmarketing commitments are clinical studies that pharmaceutical companies agree to conduct at the time of FDA approval, but which are not required by statute or regulation.
Joshua D. Wallach, Anita T. Luxkaranayagam, Sanket S. Dhruva, Jennifer E. Miller, Joseph S. Ross   +4 more
doaj   +1 more source

On the evidence consistency of pharmacovigilance outcomes between Food and Drug Administration Adverse Event Reporting System and electronic medical record data for acute mania patients

Health Informatics Journal, 2020
Evaluation of premarketing drug safety in clinical trials is often limited, due to the relatively small sample size and short follow-up time. The data collected in the postmarketing spontaneous reporting systems such as Food and Drug Administration ...
Rui Duan, Xinyuan Zhang, Jingcheng Du, Jing Huang, Cui Tao, Yong Chen   +5 more
doaj   +1 more source

Clinical pharmacology information in regulatory submissions and labeling: A comparative analysis of orphan and non‐orphan drugs approved by the FDA

Clinical and Translational Science, 2022
Clinical pharmacology is an integral discipline supporting the development, regulatory evaluation, and clinical use of drugs for the treatment of both common and rare diseases.
Julie Hsieh, Martina Sahre, Xinning Yang, Rajanikanth Madabushi, Anuradha Ramamoorthy   +4 more
doaj   +1 more source

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

, 2023
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, Vanessa Câmara Fernandes, Priscila Pentagna, Guilherme Suarez-Kurtz, Rafael Linden, Andreia Cristina de Melo, Luna Silva, Renata Obadia   +7 more
core   +1 more source

Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland

Swiss Medical Weekly, 2021
AIM OF THE STUDY In the era of pangenotypic treatment regimens against hepatitis C virus (HCV) infection, data from postmarketing observational studies are crucial to better understand the treatment patterns used in specific countries and ...
Beat Müllhaupt, David Semela, Lisa Ruckstuhl, Lorenzo Magenta, Olivier Clerc, Ralph Torgler, Francesco Negro, Nasser Semmo   +7 more
doaj   +1 more source