PK-PD Platform for Drug Discovery

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WuXi Biology scientists design the best strategies and protocols to suit our client’s needs for their lead optimizations and preclinical candidate selections with seamless integration of discovery chemistry, discovery biology and pharmacology. We offer rapid turnaround for in vitro ADME and in vivo PK screening to build the right DMPK strategy at an early stage, and target engagement to establish PK/PD correlations.

In Vitro ADME Services
in vivo pharmacokinetic studies
Bioanalysis Services

In Vitro ADME Services

We provide in vitro ADME assays & in vivo ADME studies which includes:

  • Bidirectional Caco-2 Cell Permeability, P-gp Substrate and/or Inhibitor Identification
  • Protein Binding
  • Plasma Stability
  • Blood Cell Partitioning
  • In Vitro Metabolism
  • Metabolite Identification
  • Drug Excretion

DMPK Modeling | PKPD | In Vivo PK Studies

WuXi Biology has expertise in designing, performing, and interpreting the results of in vivo pharmacokinetic studies in all species. Study design and selection of the appropriate model to be used are often customized to meet the project needs. Special surgical preparations such as catheterizations of portal vein and bile duct, can also be performed, if required. Pharmacokinetic study samples can include blood, bile, or other matrices, as well as tissues or tumor specimens that have special bioanalytical requirements. Analysis of pharmacokinetic samples is typically performed using LC-MS/MS.

We provide the following services:

  • Non-compartmental pharmacokinetics
  • Compartmental pharmacokinetics/simulations
  • Ascending dose (assessment of dose proportionality)
  • Dose linearity after repeat doses
  • Drug interaction studies
  • Pharmacodynamic and PK/PD modeling

Bioanalysis Services

In addition to our state-of-the-art analytical LC-MS/MS (with Q-trap) capabilities, WuXi Biology has a highly experienced analytical team with a track record of success in drug discovery, preclinical and clinical development. Our bioanalytical services involve the determination of drug concentrations in biological specimens derived from preclinical to clinical trials. Techniques employed include LC-MS/MS and ELISA assays.

All assays follow SOPs in which both QC/QA and GLP-compliance are implemented. Our dedicated staff with strong scientific and regulatory knowledge provides high quality of services for our clients.

Bioanalysis:

  • LC-MS/MS method development
  • MS/MS method development
  • LC-MS/MS method validation
  • Specimen analysis for preclinical and phase I through IV clinical trials
  • Analysis of common sample matrices including plasma, serum, urine, CSF, bile, and tissues
  • Animal efficacy, PK, TK, dose ranging Tox studies, in vitro metabolism, in vitro efficacy models, and protein binding
  • Metabolite identification and screening
  • Drug profiles vs. administration route
  • Free drug vs. total drug level assesement (protein binding)
  • Validation reports

Techniques include:

  • GLP-compliant LC-MS/MS analysis
  • GLP-compliant ELISA analysis