Bioanalytical Testing

ABC Laboratories offers dose formulation and routine bioanalytical testing for preclinical through Phase III clinical trials. Our bioanalytical team has developed hundreds of proprietary methods across most drug classes, and every biological matrix, and delivers expert quantitative analysis of drug and metabolites. We provide comprehensive analytical support for Human Mass Balance studies—in which we leverage in-house synthesis, dose formulation, and ADME expertise—as well as CMC support for Phase I radiolabeled studies.

Sample Analysis-Routine Bioanalysis

• Dose formulation analysis
• Quantitative analysis of drugs and metabolites in biological matrices
• Interference Testing

Immunoassays

• ELISA and RIA (¹²⁵I)

Sample Tracking and Storage

• Shipment of barcoded clinical kits to clinical site(s)
• Sample inventory and tracking by barcode
• Sample storage at -20°C or -80°C
• Dedicated staff for sample receipt & tracking

Pharmacokinetic / Toxicokinetic

• Electronic Data Transfer Results in <48-72 hours for ascending dose trials
• PK/TK analysis

Data Acquisition/Reporting

• Analyst
• Empower 2
• Win NonLin
• Sigmastat
• Daily back-up of raw data
• Detailed, customized reports & electronic reporting available