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ADME Simulations: Insights into Bioavailability and Pharmacokinetics

How Crystal Pharmatech, a leading CRDMO, leverages GastroPlus® to guide small molecule development and manufacturing decisions.


GastroPlus® Background

 

Crystal Pharmatech and GastroPlus®

1. First, we gather all available data, including:


2. Then, we build the animal models.


3. Next, we leverage the data and models built in GastroPlus® to generate human PK predictions including:


4. Finally, we analyze the parameter sensitivity to understand what we can do to maximize in vivo performance.


Outcomes:


Crystal Pharmatech background


GastroPlus® Case Study

An innovator with a first-in-class drug is heading into GLP Tox. Toxicity is difficult to obtain and the FIH dose is uncertain, so the client set a high target exposure in GLP Tox.

 

Modeling Enterohepatic Recirculation (EHC) in Dogs


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This indicated the bioavailability may not be entirely solubility limited.


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This dictated the particle size range that was adequate to achieve target.


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Solubility limited drug and increasing dose increase precipitation potential, decreasing bioavailability.


Outcome:

GastroPlus® provided the client and formulation team with critical insights to guide dosing and formulation development strategy, maximizing bioavailability and enabling the greatest flexibility in FIH dose escalation.


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bd_global@crystalpharmatech.com +1-609-604-8303
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China
No. 288, Jiangyun Road, Suzhou Industrial Park, Suzhou, China, 215123
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
bd_global@crystalpharmatech.com +1-609-604-8303