The Comprehensive In Vitro Proarrhythmia Assay: An Update

Aug 28, 2018

While the International Council on Harmonisation (ICH) S7B/E14 regulatory landscape has successfully prevented new drugs with an unrecognised propensity to induce the rare but potentially fatal ventricular arrhythmia Torsade de Pointes (Torsade) from entering the market, important and unanticipated limitations ...

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Success with Adaptive Registries in Rare Disease Research

Aug 28, 2018

Clinical research in rare diseases has become intensely competitive, with stakes that are high both for sponsors and patients. Sean Kennedy at Syneos Health describes the adaptive registries which enable meaningful and efficient evidence generation for these specialised patient populations ...

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Working with the Regulators

Aug 28, 2018

Regulators such as the FDA and EMA are often perceived as roadblocks on the route to drug approval. Their role is not to make life for drug developers difficult, as they are stakeholders in the development process, responsible for ensuring ...

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Developing Brown Fat Treatment for Tackling Obesity

Aug 28, 2018

Obesity has now reached epidemic levels worldwide. Consequently, there has been an alarming upsurge in major non-communicable diseases including type 2 diabetes, non-alcoholic fatty liver disease, coronary heart disease and cancer – all of which negatively impact life expectancy. Karin ...

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