Pharmacokinetic test / toxicokinetic test

2018-06-23

Page View：

Pharmacokinetic research is to reveal the dynamic changes of the drug in the body through the research methods of animal in vivo, external and human in vitro, obtain the basic kinetic parameters of the drug, clarify the process and characteristics of drug absorption, distribution, metabolism and excretion. Pharmaceutics, pharmacodynamics, safety evaluation research and clinical research are of great significance.

The toxicokinetics study used repeated doses of the toxicity test dose to study the dynamic changes of drugs in vivo, and obtained pharmacokinetic data. It is usually carried out in conjunction with repeated administration of toxicity tests. If appropriate parameters are determined, repeated tests can be avoided. Toxicokinetics is an integral part of the design of non-clinical trials. In understanding the results of toxicity studies and comparing them with clinical data to evaluate safety for humans, the focus is on interpreting the results of toxicity tests and increasing the value of safety assessment data.

Main research content:

Test type	Animal species	Drug type	Route of administration	research content
Pharmacy / Poison	Mice Rat Guinea pig Rabbit Beagles	Small molecule Biological Natural products Vaccine Traditional Chinese medicine	Oral: gavage, capsule Parenteral: intraperitoneal injection, intravenous injection, intramuscular injection, intradermal injection, subcutaneous injection, continuous infusion, intravitreal injection Others: nasal feeding, nasal cavity, eyes, rectum, vagina, implantation	Drug absorption, distribution, metabolism and excretion PK/TK Bioequivalence Bioavailability (po, sc, im, ip, etc.) Organizational distribution PK/PD study of a rodent disease model for dose design and dosing regimen PK research on the development and evaluation of pharmaceutical preparations Special PK studies, including food effects, gender factors, drug interactions, and the effect of gastric pH on drug PK Plasma protein binding (equilibrium dialysis and ultrafiltration)

The Pharmacy and Toxicology Laboratory has complete pharmacy, toxicology, analysis and research facilities and equipment; a rigorous and serious pharmacy and toxicology technical team. The person in charge of the pharmacy and toxicology department has rich experience in drug and toxicokinetic research. He has successively been responsible for or participated in more than one pre-clinical studies of new drugs, including drugs and toxicokinetics. Registration management requirements and ICH guidelines for subject design, implementation, and writing of subject summary reports. Our drug generation and poison generation technology team is experienced and progressive, and has the ability to provide drug generation, poison generation, and analytical research services that meet China’s GLP requirements.

The main research areas