PK-PD Platform for Drug Discovery
WuXi Biology experienced 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 a rapid turnaround 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 correlation.
The studies are performed under strict guidelines by highly trained and experienced scientists. Our goal is to meet our client’s goal of superior cost, quality, speed and service.
In Vitro ADME Services
We provide in vitro ADME assays & in vivo ADME studies which includes:
- Bidirectional Caco-2 Cell Permeability, Pgp Substrate or Inhibitor Identification
- Protein Binding
- Plasma Stability
- Blood Cell Partitioning
- In Vitro Metabolism
- Metabolite Identification
- Drug Excretion
In Vivo Pharmacokinetics and Toxicokinetics
WuXi Biology has expertise in designing, performing, and interpreting the results of pharmacokinetic studies in all species. Study design and selection of the appropriate model to be used are often customized to meet the project needs. PK studies typically involve the use of fully conscious animals that have been appropriately catheterized for drug administration and sample collection. Special surgical preparations such as catheterizations of portal vein and bile duct, can also be performed, if required. Pharmacokinetic study samples mighT 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
In addition to the state-of-the-art analytical LC/MS/MS (with Q trap) capabilities, WuXi Biology has a highly experienced analytical team led by the US major pharmaceutical company returnees with the 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. The 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 will ensure to provide high quality of services for our clients.
- LC/MS/MS method development
- MS/MS method development
- LC/MS/MS method validation according to USA standards
- Specimen analysis for preclinical and phase I through IV clinical trials
- Analysis of common sample matrices including plasma, serum, urine, CSF, bile, tissues
- Animal efficacy, PK, TK, dose ranging Tox, in vitro metabolism, in vitro efficacy models, protein binding
- Metabolite identification and screening
- Drug profiles vs. administration route
- Free drug vs. total drug level (protein binding)
- Validation reports
- GLP-compliant LC/MS/MS analysis
- GLP-compliant ELISA analysis