ADME/DMPK

Selvita offers a standard panel of in vitro ADME assays, which can be customized to fit client requirements, and provides comprehensive bioanalytical support based on our mass spectrometry platform. Our mission is to successfully support our Clients along the drug development pathway, to deliver high quality results provided by our experienced ADME specialists using state-of-the-art technologies. We provide fast turnaround times and maximum flexibility to deliver fit-for-purpose studies and achieve the specific goals of our client projects. ADME studies are offered either as stand-alone projects (fee for service model) or as a part of a collaborative Integrated Drug Discovery (IDD) program. In both cases, SLV provides a flexible approach by customizable protocols, which covers a very wide range of different needs. In addition, Selvita can propose a panel of ADME and Pharmacokinetic parameters analysis in a preassembled package which can be easily changed and customizable. The panel is ideally divided into a tiered approach depending on the drug discovery phases and then used for filtering and optimizing the ADME properties of compounds in a SAR fashion. Selvita will provide the full or partial ADME/PK package and also variants (e.g. urine analysis, tissues stability and others) following Client requests or project team decisions. Eventually, Selvita’s ADME/PK expert analysts can suggest the best compounds to be progressed into LO phase and in vivo PD experiments. Our Bioanalytical capabilities cover analyses of small molecules supporting both non-GLP as well as GLP- studies including a wide range of different activities from simple qualitative analyses to complex validation of analytical methods. Selvita also has broad experience with different sample preparation approaches using biological materials.

 

ADME tests:

Physico-Chemical Profiling

  • Kinetic Solubility
  • Thermodynamic Solubility
  • Lipophilicity (LogD/LogP)
  • pKa determination In vitro Permeability Studies Passive Transport Assessment

In-vitro Metabolism and Drug-Drug Interaction

  • PAMPA GI • PAMPA BBB Active Transport Assessment • Caco-2 Permeability
  • MDR1-MDCKII Permeability In vitro Metabolism Studies
  • Microsomal stability – liver or intestinal microsomes and homogenates
  • S9 Stability
  • Hepatocyte Stability
  • Aldehyde Oxidase reaction phenotyping
  • Plasma, whole blood and biorelevant media stability
  • Metabolite Profiling and Identification

In vitro Binding Studies:

  • Plasma Protein Binding – Rapid Equilibrium Dialysis
  • Plasma Protein Binding – High Sensitivity Binding Kit
  • Tissue Binding – Rapid Equilibrium Dialysis CYP Studies
  • Inhibition of the cytochrome P450 isoform activity (IC50, screening assay)

Bioanalytical Capabilities:

  • Method Development/Transfer/Verification/Validation
  • Qualitative Analysis
  • Quantitative Analysis Matrices: Plasma and Tissue Homogenates

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