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European Pharmaceutical Contractor

The Key to TQT

 

During the early stages of clinical development, the ability of new drugs to delay cardiac repolarisation is of key concern. As a result, dedicated clinical pharmacology studies designed to examine the effects on cardiac repolarisation have become increasingly important to the pharmaceutical industry and are today an integral component in the development of new chemical entities (NCEs) and ongoing drug development programmes for new drug submissions. These studies, known as ‘thorough QT/QTc studies’ (TQT), are now so significant that they can determine the course, and indeed the viability, of an entire drug development programme.

The first governing body to issue guidance in the form of a ‘Points to Consider’ document was the European Agency for the Evaluation of Medicinal Products (EMEA) in 1997. More recent regulatory guidance for TQT analysis has raised new considerations and challenges when designing drug development programmes. The successful completion of a TQT study in the digital ECG era is highly dependent upon superior technology and efficient, predefined processes to properly manage ECGs.

THE KEY ELEMENTS TO A SUCCESSFUL TQT STUDY

TQT studies came to prominence in order to give an early indication of QT prolongation in human subjects, as a signal of the potential of Torsades de Pointes (TdP). Through a reduction in cost by an appropriate and equal emphasis on the three key elements of these studies, TQT studies could more regularly be conducted at a much earlier stage of development of a NCE. If this were to occur, the resulting signal, positive or negative, will help shape the further development of a compound, rather than just being a regulatory necessity. The key elements to achieve a successful TQT study are:


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Asif Naseem has worked as a Medical Writer in both the medical communication agency and clinical research organisation settings. He has been involved in academic science and pharmacology in particular for over eight years. Asif currently specialises in generating clinical study protocols, clinical study reports and related material for a number of Phase I clinical trials performed at Richmond Pharmacology. Additionally, he is involved in the development and generation of posters for conferences and primary manuscripts for publication.

Keith Berelowitz has worked in both the academic and commercial environment of scientific research for more than 10 years. As Director of Operations for Richmond Pharmacology, Keith is responsible for coordinating the integration of employees and processes related to the efficient conduct of early phase clinical trials. Before taking on his current role, Keith was responsible for the recruitment of healthy and patient volunteers for early phase clinical trials (including TQT studies) at Richmond Pharmacology.

Dr Jörg Täubel is a medical practitioner and Managing Director of Richmond Pharmacology, which he co-founded in 2001. He has worked in pharmacology for nearly 20 years and during that time has conducted more than 400 early phase studies in patient, paediatric and healthy volunteers. His experience ranges from first-in-human to proof of concept studies. His particular interests are in cardiology, neurology, gastroenterology, bridging and thorough QT studies.

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Asif Naseem
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Keith Berelowitz
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Jörg Täubel
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