Results 31 to 40 of about 13,126 (223)

Clinical trial and postmarketing safety of onasemnogene abeparvovec therapy

, 2021
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, Mendell, Jerry R, Day, John W, Strauss, Kevin A, Finkel, Richard S, Reyna, Sandra P, Kleyn, Aaron, Tukov, Francis Fonyuy, Mercuri, Eugenio, Chand, Deepa H   +9 more
core   +1 more source

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   +1 more source

Development of instrument to report and assess causality of adverse events related to herbal medicines

Vitae
: Background: The use of herbal medicines is justified empirically using ethnopharmacological knowledge, which has limitations. Reports of adverse events (AE) may contribute for safety, quality, and effectiveness assessment.
Patrícia de Carvalho Mastroianni, Fabiana Rossi Varallo, Marília Amaral Costa, Luis Vitor da Silva Sacramento   +3 more
doaj   +1 more source

Uncovering Knowledge Gaps in the Safety Profile of Antiangiogenic Drugs in Cancer Patients: Insights from Spontaneous Reporting Systems Studies

Pharmaceuticals, 2023
Global repositories of postmarketing safety reports improve understanding of real-life drug toxicities, often not observed in clinical trials. The aim of this scoping review was to map the evidence from spontaneous reporting systems studies (SRSs) of ...
Valerio Ciccone, Marina Ziche, Andrea Spini, Sandra Donnini   +3 more
doaj   +1 more source

Postmarketing Evaluation of Drugs

, 2007
Round table no. 2 was devoted to the postmarketing evaluation of drugs. The debates involved both the questions posed by postmarketing evaluation and the methods for responding to them. The major categories of questions likely to be posed are as follows:
Jean-Marie Goehrs, Catherine Le Galès, Abdelkader El Hasnaoui   +2 more
core   +1 more source

Safety and effectiveness of benralizumab in Indian patients with severe eosinophilic asthma: results from the FAST study

Frontiers in Medicine
Background and objectiveThe phase IV Fasenra Safety Trial in India (FAST) assessed the safety and effectiveness of benralizumab for a period of 24 weeks in adult Indian patients with severe eosinophilic asthma.MethodsThis phase IV, single-arm ...
Deepak Talwar, Venkata Nagarjuna Maturu, Priti L. Meshram, Saurabh Mittal, Janipalli Venkata Praveen, Randeep Guleria, Randeep Guleria, Ashish Kumar, Ajay Agarwal, Ajay Kumar Verma, Murali Mohan, R. Narasimhan, Nitin Jain, Rahul Sharma, Rohit Kumar, Ujjwal Parakh, Gagandeep Momi   +16 more
doaj   +1 more source

Exposure‐adjusted safety and efficacy of GLP‐I and GLP‐1/GIP receptor agonists compared with non‐GLP‐I for weight management and type 2 diabetes: Based on FDA medical and statistical reports of 34 280 safety and 36 312 efficacy subjects

British Journal of Clinical Pharmacology, EarlyView.
Aims This work aimed to contextualize glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) and glucose‐dependent insulinotropic polypeptide (GIP) receptor agonists safety and efficacy regarding weight management (WM); we analysed Food and Drug Administration (FDA) Medical Reviews to analyse 14 medications using patient‐exposure year normalization and ...
Aishwarya Prasad, Anshu Arora, Arun Arora, Jeena Vaid, Arif Khan   +4 more
wiley   +1 more source

Statin use and the risk of tubulointerstitial nephritis: a real-world signal detection analysis using FDA Adverse Event Reporting System

Frontiers in Medicine
BackgroundStatins are widely prescribed for cardiovascular risk reduction but have been linked to a range of adverse effects. Tubulointerstitial nephritis (TIN), a potentially serious renal condition, has been sporadically reported with statin use.
Ayesha Yasmeen, Ayesha Yasmeen, Mamoon H. Syed, Mamoon H. Syed, Amani Khardali, Amani Khardali, Hadi A. Almansour, Hadi A. Almansour, Thamir M. Alshammari, Thamir M. Alshammari   +9 more
doaj   +1 more source

Practice, knowledge and attitude of physicians and pharmacists towards the spontaneous reporting system of adverse drug reactions in Switzerland

British Journal of Clinical Pharmacology, EarlyView.
Introduction Introduction Reporting adverse drug reactions (ADRs) is essential for detecting drug risks. Despite legal obligations in Switzerland, underreporting remains an issue. This study assessed practice, knowledge and attitudes towards the spontaneous ADR reporting system among physicians and pharmacists.
Fiona A. Strobel, Thomas Stammschulte, Patrick E. Beeler   +2 more
wiley   +1 more source

Evaluating effectiveness of risk minimization through healthcare professional surveys: A review of post‐authorization studies, 2022–2024

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Risk minimization measures (RMMs) are key regulatory tools to ensure safe medicinal product use. Regulatory guidelines recommend pre‐specifying the targets, or ‘thresholds’, for assessing RMM effectiveness. We aimed to review recent industry‐sponsored post‐authorization safety studies (PASS) that evaluated the effectiveness of RMMs ...
Kexin Zhu, William A. Blumentals, Froilan G. Celzo, G. Caleb Alexander, Lingyun Zhou, Juhaeri Juhaeri, Corinne Jouquelet‐Royer, Jian‐Yu E   +7 more
wiley   +1 more source