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Analysis & Reporting of QTc Prolongation Potential of New Drugs Using R Tools, Expectations & General Guidance for Regulatory Submissions

September 19, 2020 @ 8:00 am - 11:30 am

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Ana Ruiz-Garcia, PharmD, PhD, joins Dhananjay D. Marathe, PhD, to co-chair a pre-meeting workshop for the virtual American College of Clinical Pharmacology’s annual meeting. Attendees of the workshop will be able to become familiar with the ECG-pharmacokinetic analysis using R, create a report using R Markdown, Gan understanding about the sample size and exposure margin requirements for TQT substitution request based on studies without a positive control and bring a deeper understanding of some of the common challenges and potential solutions for design / analysis issues.