Small Molecule Bioanalysis

Anapharm Bioanalytics specializes in bioanalytical High Performance Liquid Chromatography Mass Spectrometry (HPLC-MS/MS) providing support to the drug development efforts of the pharmaceutical and generic industry across all stages of development including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) studies:

  • Preclinical studies
  • Phase I-III clinical trials
  • Bioequivalence studies
  • Bioavailability and drug metabolism studies
  • Drug-drug interaction studies
  • Discovery projects

Our comprehensive range of analytical services includes the following:

  • Analytical method development and validation, including proprietary methods.
  • Method transfer, optimization and cross-validation of sponsor-supplied methods.
  • Extensive portfolio of non-proprietary assays to support bioequivalence, drug-drug interaction and other types of studies.
  • Quantitative sample analysis in human and animal matrices (blood, plasma, serum, urine, faeces and tissues from diverse species) with a throughput capacity of 250,000+ samples/year. Expertise in complex bioanalysis:
  • High sensitivity assays with sub-pg/mL LLOQ
  • Long-acting injectables
  • Endogenous compounds
  • Light and temperature sensitive analytes
  • Orally inhaled drugs
  • Chiral compounds
  • Steroid hormones
  • Biomarkers
  • Analytical reports for regulatory registration.
  • Long-term matrix stability tests.
  • Long-term sample storage capacity for 300,000+ samples.

Our experienced team works in a modern laboratory equipped with 14 LC-MS/MS instruments:

  • 4 x Sciex Qtrap 6500/UPLC
  • 2 x Sciex Qtrap 5500/UPLC
  • 2 x Sciex API 5000/UPLC
  • 6 x Sciex API 4000/HPLC