chapter  4
28 Pages


WithIain J. McGilveray

INTRODUCTION As a result of 1969 amendments to the Patent Act (1) (compulsory licensing), Canadian regulators were the first to apply pharmacokinetics (PKs) to safety and efficacy risk assessment of generic drug products. However, formal guidelines developed by an Expert Advisory Committee (EAC), currently referred to as the Scientific Advisory Committee (SAC), were not published until the 1990s. Currently, guidelines are being updated and new SAC initiatives such as Guidances for nonproportional PK drugs and for drug products requiring fed studies have been published in draft form for stakeholder comments and consultation while others, such as guidance for critical dose drugs, have been finalized.