DMPK AND TOLERABILITY

Drug Metabolism and Pharmaco-Kinetic (DMPK) studies are integral to understand the life and/or stability of the drug inside the organism and thus aid in determination of the required optimal dosage of the drug. While various factors such as Absorption, Distribution, Metabolism and Excretion could have mono- or multi-variate influence on the bioavailability of the drug once administered, a proper understanding of these processes is often necessary for drug development in pre-clinical stages and could provide valuable information for dose selection in First in Human (FIH) clinical trials. Further, knowledge gained from these studies is critical for repeated compound administration.

Our research team has extensive experience in rodent disease models, a variety of routes for investigative drug administration (IP, IV, IM, SC, PO) and extraction of various tissues to determine the bioavailability of the drug in target organs.

Our DMPK analysis team has significant experience in the analytical methods of drug development including but not limited to:

1) ELISA, Sandwich ELISA and MSD platform
2) Luminex based analysis for biologics
3) Mass Spectrometry with or without HPLC

Our team can also assist with data analysis utilizing either non-compartmental or compartmental (single and/or multi-compartmental) modelling approaches and statistical analysis using SAS software.

In addition, we perform PD studies on the following NASH/NAFLD Models, Metabolic Disease Models and Muscle Disease Models.

For further inquiries, please contact us.