Non-clinical PK

Based on experience cumulated during the years and continuous improvement and innovation, we have established a comprehensive animal model library which can provide various effective animal models according to customer’s needs so that to form a reliable evaluation basis for your product’s non-clinical PK research. The experimental animals that we can provide include dogs, rats and mice, rabbits, guinea pigs, miniature pigs, monkeys, etc., to support the non-clinical PK evaluation of anti-infective and antitumor drugs, multidisciplines (including ophthalmology and pediatrics) and various diseases, such as digestive system diseases, autoimmune diseases, diabetes and complications, cardiovascular and cerebrovascular diseases, and endocrine diseases.

Service Contents

Establishment and Validation of Bioanalytical Procedures

◆Quantitative analysis of small molecules, peptides and oligonucleotides by UPLC-MS/MS

◆Quantitative analysis of chiral drugs by UPCC-MS/MS

◆Metabolite profiling and protein characterization by QTof

◆Drug analysis in vitro and in vivo by GC-MS

◆Quantitative analysis of protein and antibody as well as immunogenicity analysis by ELISA or MSD

◆Cellular and gene level analysis by PCR or living imaging method or flow cytometry or immunofluorescence method 

PK Studies in Vitro

◆Liver microsomes/hepatocytes/liver S9 metabolic stability and metabolite identification studies (humans, monkeys, dogs, rats, and mice)

◆Metabolic phenotype study (by chemical inhibition, and recombinant enzyme metabolism)

◆CYP enzyme inhibition/induction study

◆Plasma protein binding rate

◆Caco-2 permeability assay

◆Melanin binding study

◆In vitro transdermal absorption study

PK Studies in Vivo

◆Absorption and blood concentration-time curve study

◆Tissue distribution study

◆Identification and quantitative analysis of metabolites

◆Excretion study

◆Bioequivalence study

◆Interaction study

◆Blood brain barrier(cerebrospinal fluid) permeability study

PK Studies in Vitro

◆Concomitant TK of single dose toxicity test

◆Concomitant TK of repeated dose toxicity test

◆Concomitant TK of genetic toxicity test

◆Concomitant TK of reproductive toxicity test

◆Concomitant TK of carcinogenicity test

◆Concomitant biodistribution study

Featured Studies

◆Ophthalmic drug/chiral drug/prodrug PK/TK study

◆PK/TK study on the transdermal/inhaled/mucosal/intra-articular/nasal administration of drug product

◆PK/TK study on special preparations (micelles, lipidosomes, and beads, etc.)

◆PK/TK study on Traditional Chinese Medicine(TCM)

◆PK/TK study on protein peptide/antibody-based drugs

◆PK/TK study on cell and gene therapy products

◆Bioanalytical determination of endogenous substances, ultra-low drug concentration analysis, multi-analyte analysis, complex matrix sample analysis