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In vitro DMPK

Development in vitro DMPK services

Our service portfolio includes a comprehensive range of in vitro Drug metabolism and pharmacokinetics (DMPK) assays, delivering essential data for drug development. These assays facilitate a thorough understanding of a drug's absorption, distribution, metabolism and excretion (ADME), and interaction potential with drug-metabolising enzymes and transporters.
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From candidate to clinic

We possess in-depth knowledge of global regulatory requirements and assist you in navigating the complexities of drug development in compliance with the latest guidelines. By working closely with you, we develop a strong understanding of your specific needs and design assays tailored to meet your project goals. 
A scientist in a lab coat examines two vials while using a micropipette for precise liquid measurement.

Expert regulatory in vitro DMPK services

Nuvisan’s in vitro DMPK assays are designed to meet regulatory expectations, providing critical data on the pharmacokinetic properties of your drug candidate. Toxicokinetic studies are essential before exposing human subjects to a new investigational drug in a first-in-human (FiH) clinical trial. 

We determine in vitro metabolism to support or confirm the selection of appropriate toxicity species and assess the plasma protein binding of the drug candidate in both humans and animals. These regulatory-compliant assays aid in the non-clinical safety evaluation. 

Depending on the available data, we can also support these studies with relevant in vitro and/or in vivo pharmacokinetic (PK) assessments, such as intrinsic clearance and PK in rodent and non-rodent species, if needed. This enables the prediction of human pharmacokinetics to justify starting doses and potential dose escalation in FiH trials. 

In vitro investigations of drug–drug interactions (DDIs), particularly related to cytochrome P450 (CYP) enzymes, are strongly recommended for FiH trials in patients. These studies guide participant selection, concomitant medications, and define inclusion and exclusion criteria. 
Our in vitro DMPK services include assays for: 

 
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