Pharmacokinetic Research Services

Shanghai Medicilon has extensive experience in pharmacokinetics. Our pharmacy section provides customers with high-quality pharmacokinetic services from all small molecules to large molecules (proteins and antibodies), including in vitro ADME and in vivo pharmacokinetics and biological analysis. The animal species involved are non-human primates, dogs, mice, rats, rabbits, guinea pigs, etc. Among them, non-primate platforms and experimental platforms using isotope proteins/antibodies were recognized as important laboratory platforms by the Shanghai Municipal Government. The company relies on advanced analytical testing equipment and analytical laboratories that meet GLP requirements, and cooperates with GLP laboratory animal centers and Phase I clinical centers that meet AAALAC certification to provide pharmacokinetic technical services for domestic and foreign biomedical companies. .

Medicilon’s pharmacokinetics mainly studies changes in drug metabolism in the body, including the process of drug absorption, distribution, metabolism and elimination (ADME) in the body. The purpose of Medicilon is to provide high-quality data and a fast turnaround period to support various drug development, preclinical research and clinical research. The ultimate goal is to provide customers with not only a strong effect, small toxic and side effects; but also to have a good The pharmacokinetic properties of the drug. Pharmacokinetic services include: pre-clinical pharmacokinetics, pharmacokinetic studies using isotope labels, and pre-clinical pharmacokinetic application materials for new drugs.

Pharmacokinetic research directions: in vivo research, in vitro research.

In vitro study of pharmacokinetics

Mainly include drug metabolic stability in the body, P450 induction and inhibition, metabolic pathway research, metabolic product identification and other research projects, involving animals include rats, mice, rabbits, dogs, monkeys and so on.

in the body, P450 induction and inhibition, metabolic pathway research, metabolic product identification and other research projects, involving animals include rats, mice, rabbits, dogs, monkeys and so on.

Evaluation capacity: Medicilon completes an average of 8 overall outsourcing studies for new drug applications and more than 1,000 individual studies for new drug applications each year. The tested varieties include small molecule drugs, biotechnology drugs and natural product drugs

Software application: WinNolin and WastonLim software are used for data processing and analysis of pharmacokinetic research and laboratory management

Pharmacokinetics in vitro research service

• Determination of plasma protein binding rate

• Plasma stability test

• Microsomal metabolism test

• CYP450 inhibition test

• CYP450 induction experiment

• Metabolism speculation

• Confirmation of metabolites

• Metabolic pathway speculation

• Confirmation of metabolic pathways

• Transmembrane Transport Experiment

• Drug-drug interaction

Pharmacokinetic in vivo studies

Evaluation ability: Medicilon puya completes an average of 8 Package studies for new drug declaration and more than 1,000 individual studies for new drug declaration each year. The tested varieties include small molecule drugs, biotechnology drugs and natural product drugs

Software application: WinNolin and WastonLim software are used for calculation processing and analysis laboratory management of pharmacokinetic data

Pharmacokinetics in vivo research service project:

• Plasma Kinetics Study

• Organizational distribution research

• Excretion study

• Pharmacokinetic

Pharmacokinetic services include: pre-clinical pharmacokinetics, pharmacokinetic studies using isotope labels, and pre-clinical pharmacokinetic application materials for new drugs.

Preclinical pharmacokinetics

• Method development and validation (GLP, Non-GLP)

• Analysis of biological samples

• Various pharmacokinetic animal experiments

(Tumor model animals, gender differences, bioavailability, multi-cycle crossover experiments, cassette drug delivery, blood-brain barrier penetration studies)

• Drug stability study in plasma and vehicle

• Drug interaction studies

• In vitro metabolic stability studies

• CYP450 enzyme inhibition study

• Plasma protein binding rate

• Organizational distribution research

• Excretion studies

• Metabolism speculation and identification

• Toxic research

Study on pharmacokinetics using isotope labeling

• Pharmacokinetic studies of iodine-labeled protein/antibody drugs

• Organizational distribution

• Mass balance analysis

New Drug Preclinical Pharmacokinetics Declaration Information

• Declaration materials that meet FDA and SFDA new drug registration requirements

-Small molecule chemicals

-Chinese medicine

-Macromolecular protein drugs

– Monoclonal antibodies

Our staff

1. Design and implement DMPK research plan;

2. Analyze and sort out the preclinical pharmacokinetics (DMPK) and toxicokinetic experimental data;

3. Provide pharmacokinetic reports for customers and provide pharmacokinetic experiment programs;

4. Design DMPK experiment plan;

5. Has rich experience in the design and implementation of preclinical pharmacokinetic and toxicokinetic research programs;

contact us

Email: marketing@medicilon.com

Phone: 021-58591500

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