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
- 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