Results 61 to 70 of about 25,471 (263)

General practitioner consultation for postmenopausal bleeding after COVID‐19 vaccination—a self‐controlled cohort study

British Journal of Clinical Pharmacology, EarlyView.
Aims The incidence of postmenopausal bleeding (PMB) has been increasing over the past years. Little is known about the risk of PMB after COVID‐19 vaccination. Our study aimed to investigate this based on routine general practitioner (GP) healthcare data from the Netherlands.
Rana Jajou, Eugène P. van Puijenbroek, Renee Veldkamp, Jetty A. Overbeek, Florence P. A. M. van Hunsel, Agnes C. Kant   +5 more
wiley   +1 more source

The critical need for postmarketing surveillance in gene therapy for haemophilia

Haemophilia, 2020
The goal of gene therapy for haemophilia is to alter the clinical phenotype to a milder form or even cure, by increasing endogenous coagulation factor levels through transfer of a functional gene encoding the respective deficient coagulation factor and ...
B. Konkle, M. Recht, A. Hilger, P. Marks
semanticscholar   +1 more source

EudraVigilance insights: Suspected adverse drug reactions in infants through breastfeeding

British Journal of Clinical Pharmacology, EarlyView.
Aims We aimed to describe suspected adverse drug reactions (ADRs) in infants resulting from medications transmitted through mothers' milk, as reported to the European ADR database, EudraVigilance. The research sought to understand the frequency, seriousness and nature of these ADRs to assess potential risks associated with maternal medication use ...
Ida M. Heerfordt, Ditte Resendal Gotfredsen, Henrik Horwitz, Anette Kirstine Stark, Jon Trærup Andersen, Christina Gade, Ulrik Lausten‐Thomsen, Rasmus Huan Olsen   +7 more
wiley   +1 more source

Completion Rate and Reporting of Mandatory Pediatric Postmarketing Studies Under the US Pediatric Research Equity Act

JAMA pediatrics, 2019
Importance Many medicines prescribed to children have not been studied or formally approved for pediatric use. The Pediatric Research Equity Act of 2003 authorized the US Food and Drug Administration (FDA) to require pediatric clinical studies. Objective
T. Hwang, Liat Orenstein, A. Kesselheim, Florence T. Bourgeois   +3 more
semanticscholar   +1 more source

Assessment of romiplostim immunogenicity in adult patients in clinical trials and in a global postmarketing registry

British Journal of Haematology, 2020
Antibodies to first‐generation recombinant thrombopoietin (TPO) neutralized endogenous TPO and caused thrombocytopenia in some healthy subjects and chemotherapy patients. The second‐generation TPO receptor agonist romiplostim, having no sequence homology
D. Mytych, Joseph K. Park, June Kim, Troy E. Barger, A. Boshier, V. Jawa, D. Kuter   +6 more
semanticscholar   +1 more source

Prescription drug use in breastfeeding mothers and infant exposure: A register‐based cohort study

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aims Breast milk is the optimal infant nutrition; however, many infants may be exposed to prescription drugs if used by their mothers during breastfeeding. The aim of this study was to evaluate the prevalence and patterns of prescription drug use among breastfeeding mothers and to assess the availability of relative infant dose information for
Ditte Resendal Gotfredsen, Ida M. Heerfordt, Christoffer Storm Baden, Henrik Horwitz, Christina Gade, Jon Trærup Andersen   +5 more
wiley   +1 more source

Simvastatin: A Risk Factor for Angioedema? [PDF]

, 2013
Objective. To report a case of simvastatin-induced angioedema in a patient with near nightly episodes of orofacial angioedema. Case Summary. A 75-year-old African American female presented to the emergency department with recurrent face, lip, and tongue ...
Kara, Areeba, Knight, Tamara B., Nisly, Sarah A.   +2 more
core   +2 more sources

Phytochemicals in Cancer Therapy: A Structured Review of Mechanisms, Challenges, and Progress in Personalized Treatment

Chemistry &Biodiversity, EarlyView.
ABSTRACT Cancer is a major global health concern. Therefore, new treatment options are needed. The phytochemicals have different chemical structures. It also exhibits several other biological activities. Therefore, these compounds are promising anticancer agents. This review aims to identify and assess new candidates for anticancer therapy. Researchers
Alaa A. A. Aljabali, Mohammad A. Obeid, Rasha M. Bashatwah, Esam Qnais, Omar Gammoh, Abdelrahim Alqudah, Vijay Mishra, Yachana Mishra, Mohammad Ahmed Khan, Suhel Parvez, Mohamed El‐Tanani, Taher Hatahet   +11 more
wiley   +1 more source

Striking balance between expedited review and expecting efficacious anticancer drug and biologics: An ongoing challenge

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, Anita Ramesh   +1 more
doaj   +1 more source

Balinatunfib: A Clinical Oral Small Molecule TNFα Inhibitor

ChemMedChem, EarlyView.
Balinatunfib (BNF) is an oral small molecule undergoing clinical trials that stabilizes an asymmetrical TNFα (tumor necrosis factor) trimer. By locking TNF in a nonsignaling conformation, BNF achieves biologic‐like efficacy in preclinical arthritis models, potentially transforming the management of TNF‐driven inflammation. Most diseases are accompanied
Alexander Dömling, Tad A. Holak
wiley   +1 more source