In Vivo Pharmacokinetics

GQ Labs has a professional biological sample analysis team and equipment for detecting small and large molecule samples, along with an animal experimentation team for related animal test operations. We can conduct in vivo pharmacokinetic, tissue distribution, excretion, metabolite identification, mass balance, etc., studies in different animal species and via various administration routes, supporting IND and NDA submissions.

• Pharmacokinetics (PK):

o Plasma/Serum Pharmacokinetics

o Tissue Distribution (mice/rats, rabbit eyes, pig skin, etc.)

o Food Effect on PK

o Excretion (feces, urine, bile)

• Animal Species:

o SPF Animals: Rats, Mice, Guinea Pigs.

o Conventional Animals: Dogs, Rabbits, Miniature Pigs.

o Model Animals: Intestinal cannulation, bile duct cannulation, portal vein cannulation, lymphatic duct cannulation, etc.

• Administration Routes: More than 20 routes including Intravenous, Oral, Intraperitoneal, Topical application via skin, Subcutaneous, Intradermal, Sublingual, Intramuscular, Intra-articular, Pulmonary, Eye drop, Intravitreal injection, Intraduodenal, Rectal, Lymphatic cannulation, Vaginal.

• Drug and Formulation Types: Chemical innovative drugs, chemically modified new drugs, Traditional Chinese Medicine, peptides, large molecule monoclonal antibodies, bispecific antibodies, ADCs, PDCs, PROTACs, nano-formulations (liposomes, micelles, cell membrane preparations), gene therapy drugs (siRNA/ASO/mRNA), cell therapy, etc.

In Vitro Drug Metabolism and Transport

The platform can conduct in vitro metabolic stability, metabolite identification, metabolic enzyme phenotyping, protein binding rate, enzyme induction/inhibition studies, related transporter studies, etc., supporting IND submissions.

• Absorption Mechanism: Solubility experiments, LogD/LogP determination, Caco-2 permeability

• Stability Studies: Plasma/hepaticmicrosome/S9/hepatocyte/tissue homogenate/intestinal fluid/gastric fluid simulated fluid, etc.

• Drug Distribution Studies: Plasma/whole blood/microsome protein binding rate, whole blood-plasma distribution ratio

• Metabolic Enzyme Studies: Metabolic stability (hepatic microsome/S9/hepatocyte/recombinant enzyme), CYP enzyme inhibition, induction, phenotyping

• Metabolite Identification: Structural identification and semi-quantitative analysis of metabolites in in vitro incubation samples and in vivo matrix samples

• Transporter Studies: Substrate and inhibition studies for ABC and SLC transporters