Tox
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...
ADME and Drug-Drug Interactions for the Toxicologist
Highlights from the recent webinar presented by our newest expert consultant, Dr. Pallavi Limaye In her recent webinar (now available for...
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...
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