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Regulatory Guidance

Drug-Drug Interaction (DDI) Prediction Models Following In Vitro Studies in Preclinical Development

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...

What is ADME and how does it fit into drug development?

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

How can in vitro and in vivo studies help me understand my drug’s clearance?

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

Timing of In Vitro Studies: Early, Thorough ADME for Your Compound’s Success

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

How Can I Make Sure My Data Meets Regulatory Expectations?

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

What In Vitro Metabolism and DDI Studies Do I Actually Need?

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

I Have My Data… Now What?

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

The FDA has requested follow-up data… how do I fill in the gaps?

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

Why You Need QWBA for Human Radiolabeled ADME Studies

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

Transporters of Emerging Importance in Drug Development: Beyond the Guidance Documents

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

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