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View article: No Evidence of <scp>QTc</scp> Interval Prolongation With Baxdrostat Treatment: Concentration–QTc Modeling Assessment
No Evidence of <span>QTc</span> Interval Prolongation With Baxdrostat Treatment: Concentration–QTc Modeling Assessment Open
Baxdrostat is a novel, highly potent, selective, competitive inhibitor of human aldosterone synthase currently under development for the treatment of uncontrolled and resistant hypertension and chronic kidney disease. We assessed the risk …
View article: Concentration–QT modeling demonstrates that the selective mineralocorticoid receptor modulator, balcinrenone (AZD9977), does not prolong QT interval
Concentration–QT modeling demonstrates that the selective mineralocorticoid receptor modulator, balcinrenone (AZD9977), does not prolong QT interval Open
Balcinrenone (AZD9977) is a selective mineralocorticoid receptor modulator in development in combination with dapagliflozin for treatment of heart failure with impaired kidney function and chronic kidney disease. A prespecified concentrati…
View article: The myeloperoxidase inhibitor mitiperstat (<scp>AZD4831</scp>) does not prolong the <scp>QT</scp> interval at expected therapeutic doses
The myeloperoxidase inhibitor mitiperstat (<span>AZD4831</span>) does not prolong the <span>QT</span> interval at expected therapeutic doses Open
Mitiperstat is a myeloperoxidase inhibitor in clinical development for treatment of patients with heart failure and preserved or mildly reduced ejection fraction, non‐alcoholic steatohepatits and chronic obstructive pulmonary disease. We a…
View article: AZD8233 antisense oligonucleotide targeting PCSK9 does not prolong QT interval
AZD8233 antisense oligonucleotide targeting PCSK9 does not prolong QT interval Open
Aims AZD8233 is a proprotein convertase subtilisin/kexin type 9 (PCSK9) antisense oligonucleotide under development for treatment of hypercholesterolaemia. A prespecified concentration‐QT analysis was performed based on data from a single …
View article: Concentration‐QT modelling in early clinical oncology settings: Simulation evaluation of performance
Concentration‐QT modelling in early clinical oncology settings: Simulation evaluation of performance Open
Aims Concentration‐QT modelling (C‐QTc) of first‐in‐human data has been rapidly adopted as the primary evaluation of QTc interval prolongation risk. Here, we evaluate the performance of C‐QTc in early oncology settings (i.e., patients, no …
View article: Concentration‐QT modelling shows no evidence of clinically significant QT interval prolongation with capivasertib at expected therapeutic concentrations
Concentration‐QT modelling shows no evidence of clinically significant QT interval prolongation with capivasertib at expected therapeutic concentrations Open
Pharmacokinetics‐matched digital electrocardiogram data ( n = 503 measurements from 180 patients) collected in a first‐in‐human, multi‐part, dose‐escalation (from 80 to 800 mg) and dose expansion (at 480 mg) phase 1 study in patients with …
View article: Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective
Time for a Fully Integrated Nonclinical–Clinical Risk Assessment to Streamline QT Prolongation Liability Determinations: A Pharma Industry Perspective Open
Defining an appropriate and efficient assessment of drug‐induced corrected QT interval (QTc) prolongation (a surrogate marker of torsades de pointes arrhythmia) remains a concern of drug developers and regulators worldwide. In use for over…
View article: An Analysis of the Relationship Between Preclinical and Clinical QT Interval-Related Data
An Analysis of the Relationship Between Preclinical and Clinical QT Interval-Related Data Open
There has been significant focus on drug-induced QT interval prolongation caused by block of the human ether-a-go-go-related gene (hERG)-encoded potassium channel. Regulatory guidance has been implemented to assess QT interval prolongation…
View article: Issue Information
Issue Information Open
Aims and Scope: For more than 50 years, clinical pharmacologists, clinical and pharmaceutical researchers, drug development specialists, physicians, nurses, and other medical professionals have relied on The Journal of Clinical Pharmacolog…