Mandated by regulatory bodies the world over, the thorough and precise evaluation of a new drug’s cardiac effects is a critical element of new chemical entity development. Sponsors must submit all new chemical entities with systemic exposure to a dedicated thorough QT study (also referred to as TQT study) to understand the drug’s impact on ECG parameters and determine whether the compound prolongs the corrected QT (or, QTc) interval.

In Issue 9, we discuss global regulations, design, and timing of QT assessment, including a case study from a first-in-human clinical trial.

Click here to download a readable, PDF version of Issue 9: https://www.altasciences.com/sites/default/files/2022-04/The-Altascientist_issue9_TQT_2022.pdf

CHAPTERS:

- 0:08 — Section 1: Introduction

- 1:50 — Section 2: Global Regulations

- 3:49 — Section 3: QT/QTc Study Design

- 7:01 — Section 4: Timing of Assessment

- 9:36 — Section 5: Case Study — First-in-Human Clinical Trial Involving QT Assessment

- 12:09 — Section 6: Cardiac Assessment Specializations

Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.