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In the early stage of drug discovery and development, it's essential to understand the key pharmacokinetics (PK) information including absorption, distribution, metabolism, and excretion (ADME) and drug-drug interaction (DDI) properties of candidate compounds. In vitro PK studies are not only the regulatory agency's recommendations for drug development programs but also the basis for a series of subsequent studies. At Creative Biolabs, our dedicated team provides full support for your non-human primate (NHP) based in vitro PK studies flexibly and efficiently.

What Services We Can Provide

At Creative Biolabs, our in vitro PK services are launched based on collecting customer needs and suggestions and can match your R&D plan dynamically. Whether you need the help of a single piece of PK research or want to commission the entire PK project as a package, we can design the most suitable solution according to the project details you provided.

• Drug Distribution

The level of the free drug in the plasma is closely related to its exact efficacy. Thus, the rate of drug binding with plasma protein can help researchers obtain predictive information about the volume of distribution, half-life, organ distribution, and clearance of drugs. Creative Biolabs offers NHP-based drug distribution-related research including plasma protein binding (PPB), red blood cell (RBC) partitioning, and plasma stability.

• Drug Metabolism

Metabolic stability is a key factor that may lead to unexpected side effects due to slow clearance. Creative Biolabs utilizes NHP-derived microsomes, S9, and hepatocytes as in vitro models to evaluate the metabolic stability of your candidates, supporting you in achieving a balance between metabolic stability and efficacy in the drug discovery stage. If you want to analyze drug metabolic pathways and metabolites, we also have the corresponding solutions.

• Drug-Drug Interaction

Creative Biolabs offers a large range of NHP-based drug interaction assay services to reduce the risk of your candidate as a DDI victim or perpetrator.

Types of DDI services provided by Creative Biolabs

Why Partner with Creative Biolabs

Creative Biolabs values the project of each client and will impose strict quality control in the overall process of project design and implementation. We have confidence that our high-quality services will make your project a success. Don't hesitate to contact us if you have any needs.

Published Data

The article is a pivotal investigation into the pharmacokinetics of large lipophilic acids, specifically focusing on the role of organic anion-transporting polypeptides (OATPs) in their hepatic uptake in cynomolgus monkeys. This study underscores the significance of non-human primates (NHPs) in pharmacokinetic research, providing essential insights for the development of human therapeutics. The use of NHPs, particularly cynomolgus monkeys, is crucial due to their physiological and biochemical resemblance to humans. This similarity enables a more accurate understanding of drug distribution, clearance mechanisms, and the impact of OATPs, specifically OATP1B1/1B3, on the systemic clearance and distribution of these compounds. The study involved the analysis of 16 diverse compounds, investigating their behavior in the presence and absence of rifampicin, an inhibitor of OATP1B1/1B3. The findings revealed that OATP1B1/1B3 significantly influences the clearance and volume distribution of the acids, highlighting the need for precise transport characterization in pharmacokinetic modeling and prediction of drug interactions. The research demonstrates the indispensable role of NHPs in bridging the gap between preclinical studies and human clinical trials, particularly in understanding the complex interactions of drugs within biological systems that closely mimic human physiology.

Fig. 1. Comparison of in vitro uptake in human and monkey cultured hepatocytes. (A) Comparison of total uptake clearance in human vs. monkey hepatocytes. (B) Comparison of percent active uptake in human vs. monkey hepatocytes. Data points represent mean values for compounds with log P #6.5 (closed points) and log P .6.5 (open points).

Fig. 2. In vitro-in vivo extrapolation to predict monkey and human hepatic intrinsic clearance based on hepatocyte uptake data. (A) Observed vs. predicted hepatic intrinsic clearance in NHP. (B) Observed vs. predicted hepatic intrinsic clearance in human. Predictions are based on direct scaling of uptake clearance measured in cultured monkey (A) or human (B) hepatocytes in the control condition (open points) and correcting for fraction unbound in the hepatocyte incubations (closed points). (C) Observed vs. predicted human hepatic intrinsic clearance, wherein predictions are based on scaling of uptake clearance measured in cultured human hepatocytes (Human PSinf/fu,heps) corrected for compound-specific scaling factor (ratio of observed to predicted monkey clearance) obtained from IVIVE of monkey uptake clearance. (D) Observed human hepatic intrinsic clearance vs. observed monkey hepatic intrinsic clearance. Diagonal lines represent unity and 63-fold error.

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