Cardiac Safety Study

Description

The Authority has a requirement for a preclinical in vitro cardiovascular package of work. The Authority wishes to understand the cardiovascular risk and establish QT prolongation potential for a single and multi-drug combination and fulfil the ICH S7B regulatory guidance requirements. These studies are not required to be conducted to GLP but must be in compliance with ICH S7B. A Specialist Review of relevant in house and published cardiovascular safety data is also required to provide a risk assessment and data interpretation to inform decisions on the requirement for any further cardiovascular assessments. The delivery of any recommended cardiovascular assessments may be required as a further Option. A further requirement for integrated risk assessments will be included as an Option.