pk/adme

Seamless program support from oncology experts.

ADME (Absorption, Distribution, Metabolism and Excretion) studies are one of the many services TD2 offers to bring your oncology treatment to market as safely and quickly as possible. Throughout the drug development and approval process, you will have access to a wide variety of ADME assays to support your program along with input from TD2 experts early on.

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PK, PD and Biomarkers

PK, PD and Biomarkers

Everything needed for successful drug development.

Combining early PK with POC efficacy studies, we provide alignment of compound kinetics from in vitro metabolism through PD and PK testing. TD2 offers Proof of Concept (POC) for both small and large molecules of interest and provides support in the following areas:

  • Pharmacokinetic noncompartmental analysis using Phoenix WinNonlin software
  • Tissue distribution
  • Analysis of large molecules
  • Dried Blood Spot (DBS) analysis
  • LC-MS/MS and UV-VIS dose confirmation, in support of dose escalation studies
A Complete DMPK laboratory to support your assay needs

A Complete DMPK laboratory to support your assay needs.

When you partner with TD2, you can be confident that your sample analyses and results are highly reproducible and accurate. We can help tailor your DMPK panel to meet your therapeutic candidate’s requirements. Our DMPK laboratory, located within our AAALAC-accredited, state-of-the-art vivarium, is the ideal environment for cancer drug discovery to properly assesses quantitative pharmacokinetic testing and toxicokinetic analyses.

We provide bioanalytical method development and/or transfer under a non-GLP environment with proper evaluation based on

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FDA guidance. Our instrumentation includes one of the most highly sensitive LC-MS/MS equipment available, the Waters Xevo TQ-S and Acquity I-class UPLC system.

Other DMPK services we support:

  • Physiochemical properties including chemical stability
  • Stability in hepatic fractions, such as S9, microsomes and hepatocytes
  • CYP inhibition using microsomes or recombinant enzymes (supersomes)
  • High throughput screening for CYP inhibition
  • Plasma stability
  • Phenotyping in CYP or UGT enzymes
  • PAMPA screening for permeability assessment
  • Protein binding including tissue binding, blood-to-plasma ratio, and plasma protein binding
  • Bioanalytical method development and validation

PK, PD and Biomarkers

Advanced biomarker assays and analytical readouts.

Trust your research with a team of oncology experts that keep the end goal in mind. TD2 helps advance screening studies by offering various specialty assays from tumor immune cell infiltrate profiling to quantitation of the effect of therapy on the microbiome. In addition, access a wide range of standard applications through the cutting-edge MesoScale Discovery platform including:

  • Cytokines and chemokines
  • Cell signaling pathways
  • Angiogenesis and hypoxia markers
  • Growth and vascular factors
  • Metabolic markers
  • Cell based assays
  • Phosphoprotein analyses
Advanced biomarker assays and analytical readouts
Models and Services

Preclinical

Models and Services

TD2’s service offering is consistently expanding and currently includes:

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TD2 navigates the complexities of drug discovery to guide you down a smarter path for earlier, more complete results.

Contact us today to learn more about our ADME and biomarker offerings and how we
can set your treatment up for success from the start..

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