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Toxicokinetic (TK) Analysis for Preclinical Drug Development

The main goal of preclinical toxicokinetic (TK) studies is to establish a correlation between a candidate compound’s concentration or dose...

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

Drug metabolism and pharmacokinetics (DMPK) is a core discipline in drug development that considers the biotransformation of a drug compound...

Meet the Scientist: Pallavi Limaye

We have welcomed a new consultant to the team! Dr. Pallavi Limaye now serves as a Director in the Scientific...

In Vitro Evaluation of Drug-Drug Interaction (DDI) Potential

In its most recent in vitro drug interaction guidance update, the US Food and Drug Administration (FDA) emphasized harmony with the...

Four ways to optimize preclinical in vitro data to mitigate risk of late-stage clinical failure

1. Collect high-quality data to make informed, confident go/no go decisions for moving your drug candidate forward If you need...

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...

What You Need to Know About Micro-Autoradiography (mARG) Distribution Studies

In vivo determination of drug localization in tissue can be uniquely informative to drug developers investigating distribution within the context of...

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...

Mass Balance Studies: What You Need and Why You Need It

In vivo mass balance studies are an important element of nonclinical drug development, to inform first in-human (FIH) studies and to...

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...

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