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The nonclinical pharmacokinetics in the development of new drugs is mainly to study drug absorption, distribution, metabolism, excretion and drug interactions, effects of drugs on liver drug enzymes and so on. Pharmacokinetic research can not only provide evidence forclinical trial drugs, but also be used to explain the mechanism of drug actionor toxicity. Especially with higher requirement for PK / PD and toxicity generation research, pharmacokinetic research has a more important position in the development of new drugs.
Boji has set up a pharmacokinetic team that can carry out pharmacokinetic tests in vivo and in vitro, PK / PD, and clinical BE blood measurement according to the different needs of clients. A complete quality assurance system has been established and biological sample analysis is performed with reference to NMPA's GLP requirements.
Non-clinical pharmacokinetic studies (NGLP AND GLP)
●Measurement of drug-time curve (half-life t1 / 2, apparent distribution volume Vd, area AUCunder blood concentration-time curve, bioavailability F, Tmax, Cmax and other parameters)
●Bioavailability test (absolute and relative bioavailability, Coca-2 cell permeability experiment)
●Drug tissue distribution studies (drug concentrations in the heart, liver, spleen, lung, kidney, gastrointestinal tract, gonads, brain, body fat, skeletal muscle, bone marrow, etc.)
●Drug in vitro metabolism studies (in vitro metabolism studies, identification of in vitro metabolic pathways, identification of in vitro metabolites, in vitro inhibition and induction evaluation, in vitro human and animal metabolic characteristics studies, plasma protein binding evaluation)
● Study of drug protein binding rate (equilibrium dialysis method, ultrafiltration method, partition equilibrium method, chromatography method, in vitro drug competitive binding test)
● Study on liver drug enzymes (P450 enzyme system and its subtype analysis)
● Drug excretion studies(drug excretion testing in urine and feces, bile duct intubation and bile excretion testing)
● Material balance study(radioactive isotope labeling method)
● Drug PK / PD research
Animal Bioequivalence Test and Clinical BioequivalenceStudy (GLP)
● Animal Equivalence Test (NGLP) for oral solid preparations
● Clinical Bioequivalence Study (Human BE) Blood Concentration Test (GLP)
Mass spectrometry room (LC-MS / MS)
MS Control Room