Results 41 to 50 of about 11,239 (184)
Frontiers in MedicineBackground 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 +16 more
doaj +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
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
Navigating the Prescription Drug Information System
Clinical Pharmacology &Therapeutics, EarlyView.Information on new prescription drugs is increasingly complex and fragmented, posing challenges for healthcare professionals, patients, and payers. Clinicians require concise, actionable guidance to support prescribing decisions, while patients seek to balance benefits and harms when making decisions aligned with their treatment goals.
Irina V. Wang +11 more
wiley +1 more source
Clinical Pharmacology &Therapeutics, EarlyView.Postmarketing safety surveillance data identify safety issues not identified in preapproval clinical trials. We describe the frequency of new safety issues overall and by labeling section and the relationship of the most commonly added safety issues with the cumulative number of prescriptions dispensed via retail pharmacies.
Ellen Pinnow +14 more
wiley +1 more source
Postmarket evaluation of breakthrough technologies
American Heart Journal, 2008 Cardiovascular procedures performed in the United States have more than tripled in the last decade, a trend that is expected to continue with the aging of the population, coupled with epidemics of obesity and diabetes mellitus. Helping to drive this increase are new medical devices that address conditions previously treated by medication alone. Many of
Duke Clinical Research Institute and Duke University Medical Center, Durham, NC ( host institution ) +11 more
openaire +3 more sources
Clinical Pharmacology &Therapeutics, EarlyView.Precision medicine offers the opportunity to improve the benefit–risk profile of new therapies by prospectively identifying patients most likely to respond or least likely to experience harm; however, its systematic integration into drug development remains inconsistent outside oncology.
Ingrid Holst‐Laubjerg +1 more
wiley +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
Epilepsia, EarlyView.This graphical abstract provides an overview of the content from this open‐label extension study of fenfluramine use in patients with Dravet syndrome or Lennox‐Gastaut syndrome. Abstract Objective Long‐term safety and global functioning are reported in patients with Dravet syndrome (DS) or Lennox–Gastaut syndrome (LGS) treated with fenfluramine in an ...
Antonio Gil‐Nagel +18 more
wiley +1 more source