Pharmacokinetics

Pharmacokinetics

Drug Metabolism and Pharmacokinetics (DMPK)

The pharmaceutical industry faces a stark reality: only about 12% of drug candidates that enter preclinical development eventually reach the market. Many of these failures are not because a drug lacks therapeutic potential, but because of unfavorable pharmacokinetic properties or unexpected toxicity.
Drug Metabolism and Pharmacokinetics (DMPK) is a cornerstone discipline in drug discovery, playing a critical role in determining whether a promising compound can successfully become a safe, effective medicine. Its importance lies in its power to predict how a drug will behave in the body and to eliminate "losers" early, saving significant time and resources.
In PharmaResources, we have been providing DMPK services to our clients worldwide for more a decade, and successfully helped our collaborators fastened their discovery process. Our services focusing on in vitro ADME, PK, Exploratory Toxicology, and Bioanalysis. We have internal animal resources, ranging from small rodents to dog and NHPs.

In vitro ADME

  • Kinetic Solubility
  • Liver Microsomes/S9/Hepatocytes Stability
  • Plasma/Blood Stability
  • Caco-2 & MDCK-MDR1 Permeability
  • Plasma/Tissue Protein Binding
  • CYP Inhibition (IC50 and TDI)
  • GSH Stability
  • Lysosomes/Cathepsin B Stability
  • Thermodynamic Solubility (PBS/FASSIF/SGF)
  • Log D (pH 7.4)
  • Blood Plasma Partition
  • CYP Phenotyping

PK

  • Mouse, Rat, Dog, NHP
  • IP, IV, IM, PO, SC, INH etc.
  • Biological Sample Collection
  • (Blood, Plasma, Serum, Cerebrospinal Fluid
  • CSF/Brain, Tissues, Bile, Urine, Feces, etc.)
  • Rapid Formulation Screening
  • PK Screening by Cassette (N-in-1)
  • Tissue Distribution
  • Dose Proportionality
  • Single/Multiple Dose
  • PK Parameters Calculation and Interpretation
  • Peptide, ADC, ASO/siRNA PK

EXPLORATORY TOXICOLOGY

  • Animal species: Mouse, Rat, Dog, NHP
  • Dose route: IV, PO, IP, IM, SC, etc.
  • Discovery Tox, 2-wk tox
  • Dose Range Finding (DRF)
  • Single dose, Repeat dose
  • Maximum Tolerate Dosage (MTD)
  • Blood chemistry/Clinical pathology
  • Body weight, organ weight
  • Food/water consumption
  • Case-side observation
  • Toxicokinetic (TK) study

BIOANALYSIS

  • Modality of Analytes

    Small molecule, Peptide, PROTAC

    mAb, ADC, XDC

    ASO/siRNA

    PK/PD biomarkers

  • LBA/ELISA

    Generic Method for hIgG in NHP matrix

    ADA

  • ADC with LC-MS/MS

    Total ADC, total antibody

  • MD/MV

    Method development

    Method qualification/Fit-for purpose








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