Results 1 to 10 of about 25,471 (263)

Time Series Analysis of the Effectiveness and Safety of Capsule Endoscopy between the Premarketing and Postmarketing Settings: A Meta-Analysis. [PDF]

PLoS ONE, 2016
BACKGROUND:Clinical studies for assessing the effectiveness and safety in a premarketing setting are conducted under time and cost constraints. In recent years, postmarketing data analysis has been given more attention.
Kazuo Iijima, Mitsuo Umezu, Kiyotaka Iwasaki   +2 more
doaj   +3 more sources

Direct oral anticoagulant approvals by four major regulatory agencies: a cross-sectional analysis of premarket and postmarket evidence [PDF]

BMJ Open
Objectives To compare the premarket and postmarket evidence of safety and efficacy of direct oral anticoagulants approved for stroke prevention in atrial fibrillation patients across four major regulatory agencies.Design Cross-sectional.Setting European ...
Joseph S Ross, Tianna Zhou, Maryam Mooghali   +2 more
doaj   +2 more sources

Dose Determinations at Drug Approval Reviews: FDA-Approved Drugs in Past 5 Years. [PDF]

Clin Pharmacol Ther
Drug dose appropriateness is one of the most discussed issues in regulatory reviews. We analyzed dose determinations during Food and Drug Administration (FDA) drug reviews to determine whether there were changes between the proposed and approved doses of new molecular entities (NMEs), including cases where postmarketing dose‐finding studies were ...
Mita S, Ono S.
europepmc   +2 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
ABSTRACT Apremilast is a phosphodiesterase 4 inhibitor approved for moderate to severe psoriasis in Japan. Apremilast significantly improved Physician's Global Assessment (PGA) and Dermatology Life Quality Index (DLQI) both at 6 and 12 months in a previously published primary post‐surveillance study.
Ohtsuki M, Okubo Y, Saeki H, Igarashi A, Imafuku S, Abe M, Saito K, Ogawa R, Morita A.   +8 more
europepmc   +2 more sources

Postmarketing safety evaluation of belimumab: a pharmacovigilance analysis [PDF]

Lupus Science and Medicine
Objective The present study aimed to provide a comprehensive evaluation of the postmarketing safety of belimumab based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database.Methods Adverse event (AE) reports in the FAERS ...
Huqun Li, Wenlong Xie, Chongshu Wang, Cuilian Guo   +3 more
doaj   +2 more sources

An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients [PDF]

Tuberculosis and Respiratory Diseases, 2023
Background Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year ...
Eun-Yeong Cho, Jung-Eun Cho, Eun-Bin Lee, Seung Soo Yoo, Jung Hyun Chang   +4 more
doaj   +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

Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006–2021: a cross-sectional study

BMJ Open, 2023
Objective We aimed to provide insight into differences in drug review decisions made by the US Food and Drug Administration’s (FDA) accelerated approval (AA) pathway and the European Medicines Agency’s (EMA) conditional marketing authorisation (CMA ...
Yi Chen, Yue Liu, Yifei Wang, Rong Jiang, Yifan Yang, Jinping Xie, Jinlian Li, Haoyang Wang, Rong Shao   +8 more
doaj   +1 more source

PROVE: Retrospective, non‐interventional, Phase IV study of perampanel in real‐world clinical care of patients with epilepsy

Epilepsia Open, 2022
Objective To assess retention, dosing, efficacy, and safety of perampanel in a large cohort of patients with epilepsy during routine clinical care. Methods PROVE was a retrospective, non‐interventional Phase IV study (NCT03208660).
Robert T. Wechsler, James Wheless, Muhammad Zafar, Graham R. Huesmann, Marcelo Lancman, Eric Segal, Michael Chez, Sami Aboumatar, Anna Patten, Alejandro Salah, Manoj Malhotra   +10 more
doaj   +1 more source

Safety of oral nemonoxacin: A systematic review of clinical trials and postmarketing surveillance

Frontiers in Pharmacology, 2022
Background: Postmarketing safety analysis is an effective supplement for new drugs in clinical practice. Therefore, we aimed to systematically assess the safety of oral nemonoxacin malate, the first approved C-8-methoxy non-fluorinated quinolone, in ...
Jinyi Yuan, Xiaoping Zhang, Jing Chen, Yueyuan Zhang, Fengjia Zhu, Haihui Huang   +5 more
doaj   +1 more source