Results 211 to 220 of about 600,502 (290)

Maternal and Neonatal Complications Associated with Breast Cancer Systemic Treatments—A VigiBase Disproportionality Analysis Study

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Pregnancy‐associated breast cancer (PrBC) presents therapeutic challenges. Understanding maternal–fetal safety of systemic anticancer therapies is critical. We performed a case/non‐case disproportionality analysis using the WHO global pharmacovigilance database up to January 2024, to evaluate maternal–fetal outcomes associated with breast cancer (BC ...
Rayan Kabirian   +12 more
wiley   +1 more source

Intelligent Automation Improved Efficiency in Pharmacovigilance Safety Signal Assessment

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Pharmacovigilance is the science involving the detection, assessment, understanding, and prevention of adverse events associated with drugs, biologics, or medical devices. In pharmacovigilance, information that suggests a new potential causal relationship between an intervention and an adverse event is called a safety signal. Following their detection,
Jeffrey Warner   +3 more
wiley   +1 more source

Historical-Critical Dictionary of Marxism

open access: yes
Victor Strazzeri   +2 more
openaire   +1 more source

Tramadol Co‐Administration with Oxycodone or Hydrocodone Increases Opioid Burden without Improving Postoperative Pain Control

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Tramadol is frequently co‐prescribed with oxycodone or hydrocodone after surgery under the assumption that its dual mechanism of action provides an opioid‐sparing benefit. However, evidence supporting this practice is limited and inconsistent. We conducted a secondary analysis of the multicenter IGNITE ADOPT‐PGx pragmatic trial of patients undergoing ...
Noor A. Nahid   +302 more
wiley   +1 more source

Enhancing Evidence Generation by Linking Randomized Clinical Trials to Real‐World Data: The INVESTED‐Medicare Linkage Study

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Real‐world evidence (RWE) derived from real‐world data (RWD) can complement randomized controlled trials (RCTs), yet the validity of RWD relative to RCT data remains insufficiently characterized. We obtained post hoc consent and linked individual participant data from the US‐based INVESTED trial (2016–2019) with Medicare fee‐for‐service claims (2012 ...
Hanseul Cho   +12 more
wiley   +1 more source

Special Populations in Pivotal Clinical Trials: Eligibility and Supporting Evidence for Exclusion in EMA‐Authorised Medicines

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
Evidence on the efficacy and safety of medicines supporting marketing authorization is largely derived from randomized controlled trials, yet these trials often exclude populations likely to use the medications in clinical practice. This study assessed eligibility of special populations, defined as pregnant and breast‐feeding individuals, elderly ...
Maja J. Jørgensen   +2 more
wiley   +1 more source

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