Regulatory Guidance

In preclinical development, a drug will be evaluated for potential to cause a drug-drug interaction (DDI) using in vitro experiments and then calculations that...

The main aim of drug development is to get a compound that has a therapeutic effect into the form of...

Systemic clearance, denoting how much drug is cleared from a volume of blood per unit of time, is of critical...

Beyond the need for evidence that a drug works, Food and Drug Administration (FDA) and other regulatory bodies around the...

Regulatory authorities publish updated guidance documents that share their expectations for endpoints and test systems with drug developers, but sometimes it is difficult to...

Though there is no ‘roadmap’ spelling out required studies to achieve regulatory approval for clinical entry, a drug candidate’s metabolism...

As a drug moves through the development pipeline, it undergoes a rigorous battery of safety assessments to prove it will...

Because each new drug is unique in characteristics, such as chemical structure, mechanism of action, and physicochemical properties, there can...

A quantitative whole body autoradiography (QWBA) study provides data required for Human Radiolabeled ADME Studies1. Quantitative whole body autoradiography (QWBA) is an in...

Dr. Ogilvie’s presentation discussed critical literature and case studies which have been published since the FDA’s most recent guidance revision issued in...