Neelima Thanneer
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View article: Characterization of mavacamten pharmacokinetics in patients with hypertrophic cardiomyopathy to inform dose titration
Characterization of mavacamten pharmacokinetics in patients with hypertrophic cardiomyopathy to inform dose titration Open
Mavacamten is a selective, allosteric, reversible cardiac myosin inhibitor that has been developed for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). A population pharmacokinetic (PopPK) model was d…
View article: Recommendation of mavacamten posology by model‐based analyses in adults with obstructive hypertrophic cardiomyopathy
Recommendation of mavacamten posology by model‐based analyses in adults with obstructive hypertrophic cardiomyopathy Open
Mavacamten is the first cardiac myosin inhibitor approved by the US Food and Drug Administration for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). The phase III EXPLORER‐HCM (NCT03470545) study use…
View article: PmWebSpec: An Application to Create and Manage CDISC-Compliant Pharmacometric Analysis Dataset Specifications
PmWebSpec: An Application to Create and Manage CDISC-Compliant Pharmacometric Analysis Dataset Specifications Open
A well-documented pharmacometric (PMx) analysis dataset specification ensures consistency in derivations of the variables, naming conventions, traceability to the source data, and reproducibility of the analysis dataset. Lack of standards …
View article: A systematic approach for imputing missing dose information in population pharmacokinetic analysis datasets
A systematic approach for imputing missing dose information in population pharmacokinetic analysis datasets Open
View article: Population Pharmacokinetics of Apixaban in Subjects With Nonvalvular Atrial Fibrillation
Population Pharmacokinetics of Apixaban in Subjects With Nonvalvular Atrial Fibrillation Open
This analysis describes the population pharmacokinetics ( PPK ) of apixaban in nonvalvular atrial fibrillation ( NVAF ) subjects, and quantifies the impact of intrinsic and extrinsic factors on exposure. The PPK model was developed using d…