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Method Development

 
Advanced methodologies. On time performance.

 

Notrox offers custom method development, assay validation, and sample analysis using state-of-the-art LC/MS/MS assays and a team of detail oriented scientists. Our staffs have developed LC/MS/MS methods including routinely quantifying levels below one pg/ml. We have methods for multiple analytes, metabolites, prodrugs and light- and temperature-sensitive compounds. Notrox scientists also have considerable expertise in developing methods for immunoassays (ELISAs and other ligand binding assays) and cell-based assays.

 

Notrox bioanalytical labs offer substantial capacity and expertise in the highly demanded bio-analysis technique of chromatography. We have applied LC/MS/MS to compounds that range from small molecules to peptides with measurement in biological fluids and tissues. We utilize the most advanced automated sample cleanup techniques for rapid sample analysis and employ stable isotope internal standards for precise and accurate quantification. Our extensive scientific and technical expertise includes:

 

  • Highly diverse range of analyses
  • Difficult endogenous, reactive or unstable types of analyses
  • Ultrahigh sensitivity assays with sub-pg/ml lower limits of quantification (LLOQ)

 

Because we recognize the need for rapid method development, sample analysis can typically be performed within a few days. We can also work closely with your scientific staff to validate methods, and to ensure that assays have demonstrated linearity, recovery, reproducibility, specificity, accuracy, and stability under all conditions. All Notrox method validations are performed according to Good Laboratory Practices (GLP), and adopt all guidelines.

 

We also coordinate with,

  • Analytical Support – Alliance Partner Service
  • Discovery and GLP-compliant bioanalytical chemistry services
  • Sample Analysis-Routine Bioanalysis
  • Quantitative Analysis of Drug and Metabolites in Biological Matrices
  • Dose Formulation Analysis, Interference Testing
  • Analytical Method Development, Validation (Full, Cross, & Partial), Method Transfer & Sample Analysis (LC-MS/MS, HPLC, ICP-MS, and Immunologists)
  • Dose Analysis
  • Metabolite Characterization & Identification
  • Immunoassays
  • ELISA
  • Method Development and Validation, Routine Sample Analysis

 
Notrox can also work with the Sponsor’s in-house analytical laboratory or with a Sponsor designated analytical laboratory in support of the studies.