Early Drug Development Solutions

Bioanalytical & Pharmacokinetics

Early stage pharmacokinetic data are essential for new chemical entities for proper design of animal pharmacology and toxicology studies. NAEJA pharmaceutical Inc. offers complete package of analytical method development, pharmacokinetic evaluation & parameter calculation in mice and rats.

  • Bioanalytical assay development and validation for trace level analysis of drugs and/or metabolites in biological fluids and tissues:
    • Method development using HPLC for high capacity LC for routine analysis
    • Capabilities in LC/MS/MS for applications in both Electrospray (ES) and atmospheric pressure chemical ionization (APCI) interfaces for quantitative analysis and qualitative drug/drug metabolite identification

  • Pharmacokinetic studies in rodents & with bioanalysis & PK parameter calculations
    • Bioavailability studies
    • Blood/plasma concentrations
    • Tissue concentration/distribution

  • Preliminary Acute and Sub-Acute Toxicity Studies