PK/PD Studies

Category: Drug Discovery

●Senior professional talents ●Leading and solid experience ●Customized service on demand

Detailed introduction

The preclinical pharmacokinetics service department of KS-V Peptide has a group of senior professionals with solid theoretical knowledge and rich experimental experience, who lead the work of experimental design, experimental implementation, biological analysis and data analysis. The experimental research of KS-V Peptide follows the guidelines of ICH, NMPA and FDA. It can design and carry out in vivo and in vitro pharmacokinetic tests according to customer needs, and provide customers with a complete set of pharmacokinetic evaluation and optimization services. KS-V Peptide Pharmacokinetics service provides high-quality data and efficient experimental cycle to meet the needs of customers from early drug discovery to new drug application, and has been well received by many customers at home and abroad.

Detection and Analysis

• Establishment of PK analysis method for biomacromolecules

• Establishment of ADA analysis method (ELISA/MSD)

• Biological sample analysis (chemical small molecules/biomacromolecules)

• Analysis of clinical biological samples for bioequivalence testing

• Pharmacodynamic study and animal histopathological study

• Animal bone marrow smear and diagnosis

Early toxicity screening assay (non-GLP)

• Animal experiment liver cell line/kidney cell line/hERG/

• Mitochondrial toxicity, etc.

• Drug interaction studies

• Safety pharmacological screening experiment (awake animals)

Pharmacological and toxicological experiments (non-GLP)

• Animal single and repeated drug given toxicity test

• Toxicogen analysis

• Special toxicity test

• Carcinogenicity test

• Reproductive toxicity test

• Genotoxicity test

• Safety pharmacology test

Pharmacokinetic and toxicokinetic studies

• Single and multiple drug given PK studies of different species and different routes of administration

• Toxicokinetic studies of different species

• Tissue distribution studies of drugs in animals

• Drug excretion studies

In vitro study of drugs

• Drug liver microsomes and hepatocyte metabolism studies

• Structural identification and quantitative analysis of drug metabolites

• Drug metabolizing enzyme phenotype studies

• Induction and inhibition of CYP450 enzymes by drugs

• Cell permeability study of drug Caco-2

• Drug and plasma protein binding rate test

• Comparative study on the metabolism of hepatocytes

• efflux transporters (P-gp, BCRP, MRP2, etc.) and uptake transporters (OATP, OCT, etc.)

Generic Drug Bioequivalence Studies

• Bioanalytical method development and validation

• Biological sample analysis

• CTD report writing

• PK parameter statistics

• Biological sample storage