The European Union (EU) Paediatric Regulation requires that all new medicinal products applying for a marketing authorisation (MA) in the EU provide a paediatric investigation plan (PIP) covering a ...

Extrapolation estimates a variable's value beyond its initial observation range based on relationships with other variables. Unlike interpolation, extrapolation carries greater uncertainty and risks ...

FOCUS: A recent High Court decision will provide helpful guidance to parties that elect to use statistical sampling and extrapolation as a means to demonstrate entitlement to substantial damages.