DMPK or Drug Metabolism and Pharmacokinetics is a major part of studies related to drugs often referred to as ADME (Absorption, Distribution, Metabolism and Elimination). It is concerned with the study of aspects of absorption, distribution, metabolism and elimination of drug compounds which are administered through any route of administration.
Drug Metabolish and Pharmacokinetics are specific to drug discovery; drug properties such as route of administration, dose level, dose regimen and formulation, drug-drug interactions and specific populations are all tightly related to DMPK and are therefore measured by our experts. Our DMPK Department is dedicated to the understanding of the absorption, distribution, metabolism and excretion of drug candidates.
Medicilon’s pharmacokinetics department offers the clients a broad spectrum of high quality of services in the areas of in vitro ADME, in vivo pharmacokinetics and bioanalysis services, ranging from small molecules to large molecules, such as protein and antibody. The animal species involved in our DMPK cro services are non-human primate, canine, mice, rat, rabbit and hamster. Meanwhile, non-human primate experimental platform and isotope platform for protein/antibody are certified by the Shanghai Government.
Available studies include:
- Method development and validation (GLP & Non-GLP)
- Pharmacokinetics (Tumor bearing rodents, Bioavailability, Crossover studies, Cassette (N in 1) dosing and analysis, effects of gender on pharmacokinetics, BBB penetration )
- Stability in vehicles and plasma
- Drug interaction studies
- In vitro metabolic stability
- Prediction and identification of major metabolites
- Toxicokinetics analysis
- Distribution studies
Pharmacokinetics Package for IND Filing
DMPK package for CFDA and FDA IND filing
- Chemical Compounds
- Traditional Chinese Medicine
Metabolic Stability Services
- CYP Reaction Phenotyping
- Microsomal Stability
- S9 Stability
- Hepatocyte Stability
- Plasma Stability
- Metabolite Profiling & Identification
Drug-Drug Interaction Services
- Cytochrome P450 and UGT Reaction Phenotyping
- Hepatocyte Induction
- Cytochrome P450 Inhibition
- Time Dependent Inhibition (Single Point)
Permeability and Transporter Services
- Caco-2 Permeability
- P-gp Inhibition
DMPK: Available reaction phenotyping services include:
- Phase I:
- Cytochrome P450 Enzymes (CYP)
- Phase II:
- UDP-glucuronyltransferases (UGT)
- Microsomes stability
- Hepatocytes stability
- Plasma stability
- S9 stability
Protein Binding Services
- Plasma Protein Binding
- Brain Tissue Binding
- Whole Blood Binding
- Blood to Plasma Ratio
In vitro DMPK
High quality ADME data is essential to identify and help to address issues rapidly and early in the drug discovery, lead validation and optimization processes. The in vitro ADME service offers a portfolio of assays for investigating physicochemical properties, permeability, metabolism, drug-drug interactions (CYP inhibition, induction and phenotyping) and protein binding. These assays are offered either as a standalone services or to support our client sponsored medicinal chemistry programs.
In Vivo Pharmacokinetics
We can perform in vivo animal pharmacokinetic (PK) and other ADME studies in mice and rats in our CPCSEA approved AAALAC-accredited animal facility. We have a third party collaboration (CPCSEA approved facility) to perform pharmacokinetic studies in dogs.
A quantitative measure of drug exposure is necessary in order to interpret preclinical efficacy and toxicity studies. In a typical animal PK study, blood samples are obtained from animals at different time points following a single dose of a test compound. Plasma is harvested and subjected to bioanalysis. In an absolute bioavailability study of an orally administered drug, both oral and IV PK has to be performed. Relative oral bioavailability studies with different formulations can be carried out to enable selection of appropriate preclinical formulation for any compound. In toxicology studies, a satellite toxicokinetics group is included so as to assess the NOAEL (No Observable Adverse Effect Level) for any compound.
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