August 12, 2024
HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]
August 12, 2024
In 2020, CDER’s Office of Generic Drugs (OGD) and several partner researchers quantified the effect of drug solubility and partition coefficient on the dissolution and subsequent […]
August 12, 2024
Pharmacometric Models as Tools in Drug Development and Review Pharmacokinetic (PK) models are increasingly relied upon in drug development and review. Typically consisting of a set […]
August 12, 2024
CDER researchers and collaborators at NCTR are developing pharmacometric models that can support software tools that can be used by clinicians to guide drug dosing for […]
August 12, 2024
Over the past decade, progress has been made in planning and conducting clinical trials for rare disease drug development. In 2018, for the first time ever, […]
August 12, 2024
TOPLINE: A novel method combining genetic variants, symptoms, and patient characteristics is moderately successful at predicting which primary care patients are at high risk of developing […]
August 12, 2024
TOPLINE: The first year after the diagnosis of systemic lupus erythematosus (SLE) is crucial, with the highest percentage of patients experiencing organ damage. Cardiovascular issues are […]
August 12, 2024
TOPLINE: Among patients with overweight or obesity, frontline immunotherapy for advanced non–small cell lung cancer (NSCLC) was not associated with a survival benefit compared with conventional […]
August 12, 2024
TOPLINE: The estimated number of US adults who consumed at least one of the six most frequently reported hepatotoxic botanicals in the last 30 days is […]
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