PK and TK Study

Pharmacokinetics studies the dynamic changes of drug metabolism in the body, including adsorption, distribution, metabolism and excretion (ADME). The toxicokinetics which is based on the principles and methods of pharmacokinetics, is to quantitatively study ADME and characteristics of drugs in animals at toxic doses. TK helps to know the distribution and target organ of drug in animals, and supplies basis for other toxicity tests and results evaluation. Our center has radiation safety license and class C unsealed radioactive material workplace, and PK and TK study of radioisotope labeled drug could be carried out.

Service items

1.PK

Preclinical adsorption, distribution, metabolism and excretion (ADME) study of drug in mouse, rat, dog, pig and monkey.

Metabolism study in Vitro;

Bioavailability and bioequivalence study of animals and human.

2.TK

To perform TK study in accordance with CFDA GLP;

To perform TK study accompanied with single and repeated administration toxicity test, short-term toxicity test, long-term toxicity test and reproductive toxicity test.

3.Radioisotope tracer technology

Synthesis of low energy radioisotope (3H and 14C) labeled compounds;

PK and TK study of radioisotope labeled drug, including absolute bioavailability, tissue distribution, biotransformation and excretion of feces, urine, bile and exhaled gas (material balance);

Radioisotope labeled samples could be detected, including biological samples, plant samples, soil and water samples, etc.

Compliance guidelines

Good laboratory practice for Non-clinical drug research;

Guidelines for non-clinical pharmacokinetic studies published by CFDA CDE;

Relevant guidelines published by ICH;

Relevant chemical test guidelines published by OECD.

Qualification platform

"National Center for Safety Evaluation of New Drugs in Shenyang" approved by the Ministry of Science and Technology;

"Liaoning New Drug Safety Evaluation Technology Research Center" recognized by Liaoning Science and Technology Department;

Class C unsealed radioactive material workplace;

OECD GLP、CFDA GLP、AAALAC;

Pass the US FDA GLP inspection in 2018.

Instrument and equipment

AB API 4000 Qtrap  (LC-MS)、AB API 5500 Qtrap  (LC-MS)、Thermo Finnigan  (GC-MS)、Agilent 1200  (HPLC)、Waters  (UPLC)、Agilent 6890  (GC)、 LSQ、HPLC-ARC、Oxidation burner.

Waters SDMS LIMS; 24-hour temperature monitoring system; Standardized sample management and archives management system; Perfect SOP management system.

Business consulting

Ms.Li   +86   024-85869185/ 18540366476