Animal PK

• Full PK studies in rodents, dogs, and monkeys
• Animal dosing formulation screening
• Single and multiple dose PK studies
• Dose escalation studies
• Pre-clinical Bioequivalence studies
• Non-GLP Toxicokinetics (TK) studies
• Calculation of PK Parameters and Bioequivalence using WinNonLin

In-Life Capabilities

• Species include rat, mouse, nude mouse, guinea pig, mini-pig, rabbit, cat, dog, and monkey
• Drug dosing via IV bolus/Infusion, PO, SC, IP and IM, etc. and blood sampling
• Surgery for bile duct cannulation and CSF collections
• Bile, urine and feces collections
• Brain, liver, kidney, marrow and other tissue collection
• Exploratory rat, mouse & dog Tox studies

In vitro Studies

• Permeability Studies: PAMPA, Caco-2, MDR1-MDCKII
• Transporter studies: Substrate and inhibition, including P-gp, BCRP, MRP2, etc
• Distrbution: Blood/plasma ratio, Plasma/Brain ratio
• Protein binding: Plasma/microsomes, method as following RED and Ultrafiltration
• Matrix Stability studies: Blood/plasma, PBS, SCF/SIF and tissue homogenate, etc
• Metabolism stability: Microsomal/hepatocyte, S9, CYP and UGT supersomes, tissue homogenate and blood/plasma
• CYP450 reaction phenotyping
• Drug- drug interaction: CYP450 Inhibitions (Reversible inhibition, TDI, IC50 & Ki/Kinact), CYP450 inductions (Enzyme activity &mRNA) and transporter inhibition
• Metabolite identification (MID) in liver microsomes, plasma, urine, feces, tissues and metabolic profile species comparison
• Solubility, Log D and pka, etc

Bioanalytical Services

• Bioanalysis consistent with CFDA&FDA IND new drugs
• Method development and method validation following FDA guidance & CFDA guidance
• Sample bioanalysis of rodents, dog and monkey PK studies, tissue distribution, in vitro study
• Drug quantification in plasma and tumor samples for PK/PD study
• Expertise in small molecule compounds, peptides, oligonucleotides, and some endogenous drugs
• LC-MS/MS: AB API4000/Qtrap5500, SHIMADZU LC30AD UPLC

Provides a full preclinical pharmacokinetic and metabolism services for IND submissions

Broad Range of Bioanalysis Services

• Small molecules (drugs and endogenous material)
• Peptides, olionucleotides
• Plasma, serum, bile, urine, feces, all tissues and tumor
• Biologics, antibodies ELISA

GLP Compatible

• Over 80 SOPs and their training records
• GLP notebooks and storage
• LC-MS/MS and freezer qualification and logbooks
• GLP biologics/ELISA analysis

Method Validation (CFDA/FDA)

• Standard curve, QCs and LLOQ
• Accuracy and precision
• Specificity and selectivity
• Matrix effect and recovery
• Dilution linearity and stability

Bioanalysis Support

• PK, PK/PD and TK studies
• Bio-equivalent studies
• Metabolism studies
• Clinic PK samples