Team Background
The DMPK division of ZSHK Laboratories Limited mainly studies the absorption, distribution, metabolism, excretion and other processes of compounds in the body, and now has the functions of in vivo PK research (rodent/non-rodent absorption, tissue distribution, excretion, etc.) and in vitro metabolism research (liver microsome/hepatocyte metabolic stability studies, metabolite identification studies, in vitro inhibition and induction studies, in vitro phenotype studies, etc.), covering the entire DMPK chapter for new drug application. The current capacity of carrying out in vivo and in vitro ADME early screening studies and studies for IND application allows the team to provide customers with high-quality technical services that meet the requirements of regulatory agencies.
Key Equipment
Featured Services
In addition to a full set of DMPK studies that meet the application requirements, the DMPK division carries out early screening tests and clinical trial-supporting tests to cover all stages of drug development
1. Lead screening
Preliminary study on PK profile in rodent/non-rodent in vivo
Screening of metabolic profile of liver microsomes from different species in vitro
Rapid screening of metabolites in vitro
Preliminary identification of metabolic enzyme isoforms in vitro
In Vitro Penetration Test
Preliminary screening of major efflux transporters in vitro
2. Preclinical DMPK study (IND PK)
Biological Sample Analysis Method Development and Validation
In vivo pharmacokinetics, oral bioavailability and dose linearity studies in rodent/non-rodent animals
Rodent tissue distribution and excretion studies
Study on the metabolic stability of liver microsomes/hepatocytes
Metabolic enzyme isoform identification, inhibition and induction studies
Metabolite Identification Research
In vitro protein binding studies of different species
Transporter Interaction Studies
3. Preclinical safety evaluation studies
Safety evaluation animal species confirmation/biological sample analysis (toxicokinetics)
4. Clinical stage
ADME characterization of high ratio metabolites
5. Approval and Postmarketing
Potential drug-drug interaction studies
