Results 41 to 50 of about 13,126 (223)
Pediatric Developmental Safety Assessment: Are We Ready for the Next Thalidomide?
Clinical Pharmacology &Therapeutics, EarlyView.Pediatric drug development has achieved remarkable success in the last 20 years with over 1,000 products studied in pediatric patients. This success has been driven in part by an increased understanding of pediatric disease processes. The aspect that has been largely overlooked is the potential adverse effect of new drugs on pediatric developmental ...
Gilbert J. Burckart +6 more
wiley +1 more source
Current Oncology, 2023 The present study analyzed the characteristics of phase IV clinical trials in oncology using data from the ClinicalTrials.gov registry. The included trials were conducted between January 2013 and December 2022 and were examined for key characteristics ...
Brandon Michael Henry +3 more
doaj +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Antibody–drug conjugates (ADCs) combine the specificity of an antibody with the potency of a cytotoxic drug. Thirteen ADCs, utilizing seven unique cytotoxic payloads and targeting 11 distinct antigens, are currently approved by the US Food and Drug Administration as of June 2025, representing a rapidly growing and highly promising class of anticancer ...
Sijie Lu +6 more
wiley +1 more source
Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer
Iranian Journal of Neurosurgery, 2019 Background and Aim: Cranfixer was approved in 2017 by the Food and Drug Administration of Iran as a skull flap fixation and also a burr hole cover.
Seyed Roholah Ghodsi +3 more
doaj
Epilepsia Open, EarlyView.The impact of prompt diagnosis and treatment, and early predictors of outcome severity in this cohort. Abstract Objective Most therapies for drug‐resistant epilepsy (DRE) focus on focal‐onset seizures, the most common seizure types. Studying primary generalized tonic–clonic seizures (PGTCS) is more challenging due to diagnostic and recruitment ...
Katherine Eggleston +6 more
wiley +1 more source
Knee Surgery, Sports Traumatology, Arthroscopy, EarlyView.Abstract Purpose This registry study aimed to evaluate the safety and effectiveness of collagen membrane‐covered matrix‐associated autologous chondrocyte implantation (cMACI) versus periosteum‐covered MACI (pMACI) for large knee cartilage defects (Outerbridge III–IV, ≥4 cm²) in the femorotibial and/or patellofemoral joints with a minimum 2‐year follow ...
Yuji Uchio +4 more
wiley +1 more source
Systematic postmarketing surveillance needed for misused psychoactive pharmaceutical drugs
, 2023 Systematic postmarketing surveillance needed for misused psychoactive pharmaceutical ...
Tracy W Soh (13465329)
core
Neurology and Clinical Neuroscience, EarlyView.ABSTRACT Background Glatiramer acetate is an injectable disease‐modifying therapy indicated for multiple sclerosis (MS). Aim To evaluate the real‐world safety and effectiveness of glatiramer acetate for MS in Japan. Methods A prospective, multicenter, observational, all‐case post‐marketing survey was conducted in Japan between November 2015 and March ...
Masaaki Niino +3 more
wiley +1 more source
Changes in the heterogeneity when each postmarketing study is excluded.
, 2016 Changes in the heterogeneity when each postmarketing study is excluded.
Mitsuo Umezu (804421) +2 more
core +1 more source
Perspectives in Clinical Research, 2017 Objective: The objective of this study is to assess the postmarketing status: Efficacy and safety drugs and biologics related with cancer approved under expedited review.
Krishnan Vengadaragava Chary +1 more
doaj +1 more source