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DMPK

SERVICE AREAS & COMPETENCES

Service Areas

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

Core COMPETENCES

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

other discovery