Toxicokinetics

Medicilon has complete pharmacokinetic, toxicokinetic and analytical research facilities and instruments. Our Toxicology Research Department has been granted AAALAC Accreditation and GLP certificate from the NMPA and passed the on-site evaluation, with capabilities to support filing programs for multiple countries.

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Pharmacokinetic analysis can reveal the dynamic changes of drugs in vivo, the basic pharmacokinetic parameters of drugs, and clarify the process and characteristics of drug absorption, distribution, metabolism and excretion. It is an important starting point for animal species selection and understanding the relationship between dose-effect and toxicity-effect and can provide relevant information for designing and optimizing administration in clinical trials.

Toxicokinetics is an important part of pharmacotoxicology. It mainly studies the whole body exposure degree and duration of the tested substance at different dose levels to predict the potential risks of the tested substance when it is in the human body. Toxicokinetic tests are not a simple description of the basic pharmacokinetic parameters of drugs, they focus on explaining the results of toxicity test and predicting human safety.

Service

In vitro ADME research
Metabolic stability (liver microsomes, S9, Cytosol, hepatocytes and blood)Metabolite identificationDetermination of plasma protein binding rateCYP enzyme inhibition research (DDI and TDI)CYP enzyme induction researchTransporter substrate and inhibition evaluationEnzyme phenotype analysis
In vivo PK research
Selection of solvents and preparationsBridging experiment of preclinical preparation and clinical preparationBioavailabilityTissue distributionBile, urine and feces excretionBE researchPK/PD research Identification of metabolites in vivo
In vivo TK research
TK/PD/TOX analysisGender difference/dose correlation/accumulation analysisActive ingredient/prodrug/metabolite monitoringIdentification of metabolites of TK samplesImmunogenicity analysis
Biological sample analysis
Bioanalysis of preclinical samplesBioanalysis of clinical samplesanalysis of BE samples