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Updated Q&A document clarifies key issues of the ICH E14 Guidance

A revision of the ICH document titled E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs – Questions and Answers (November 2008) has been issued.

Since the ICH E14 guidance was finalized, experiences implementing the guidance in the ICH regions gave rise to requests for clarification. As a result, a question and answer (Q&A) document was created to facilitate the implementation of the E14 guidance by clarifying the key issues in 2008 and has since been updated to address additional questions.

As a member of the Cardiac Safety Research Consortium (CSRC), Altasciences participates with industry leaders on crucial matters that impact cardiovascular safety, including alternative approaches to ICH E14 for the assessment of arrhythmia liability in early drug development. We are well-positioned to support the classic thorough QT studies and/or today's early precision QT studies.

 

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Dr. Martin Kankam, MD, PhD, MPH

NEW CARDIAC TECHNOLOGIES AND EARLY CARDIAC SAFETY ASSESSEMENT

Dr. Martin Kankam, MD, PhD, MPH, and our many other experts advise on early cardiac assessment trials at our iCardiac-certified Montreal and Kansas sites, from study design and conduct, to data interpretation and the required regulatory communications. The expertise of the technical staff at our state-of-the-art clinical pharmacology campuses built purposely for early phase clinical trials is key for the successful completion of these complex cardiac safety studies.

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Cardiovascular Safety Assessment in Early Phase Clinical Studies | Classic Thorough QT Studies vs. New Early Precision QT Studies
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PHARMAVOICE100:
ANOTHER AWARD
TO BE PROUD OF!

Our congratulations go out to Altasciences' CEO, Chris Perkin, who was named one of PharmaVOICE's 100 Most Inspiring Leaders in the life-sciences industry for a third consecutive year.

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Case studies on the use of MitraTM VAMS technology, from product characterization to applications development, implementing a novel impact-assisted extraction technique.

CANADA TALKS PHARMA SEPT. 11-12, WESTIN MONTREAL

Our very own Graham Wood presents Collaborating with Hospitals on Recruitment for Clinical Pharmacology Studies on Sept. 11. See you there!

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