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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.


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





This indicated the bioavailability may not be entirely solubility limited.


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


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


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
Suite 500-B, 3000 Eastpark Blvd, Cranbury, New Jersey 08512, USA
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Suite B4-101, Biobay, 218 Xinghu Street, 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