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Purdue Research Park
West Lafayette, IN 47906 US
Toxicology Services: Acute Toxicology, Sub-chronic Toxicology, Chronic Toxicology, Carcinogenicity studies, Behavioral toxicology, Immunotoxicology and biomarkers, Clinical chemistry and pathology panels, Necropsy and histology with special stains, Pharmacokinetics and drug metabolism, Bioanalytical Services include:
* GLP or non-GLP Method development and validation * Drug interaction, ADME, PK * Study sample analysis * LC-MS/MS (triple quadrupole) * HPLC * Immunoassays
Capabilities: * Three major LC-MS/MS platforms (40 instruments) * LDTD rapid sample analysis * Immunoassay robotics and microplate readers * Automated 96-well sample preparation * Conventional HPLC with UV, fluorescence, and electrochemical detection * Low temperature storage * Analysis of unconventional biological tissues * Part 11-Compliant Software Systems
Pharmaceutical Services include:
* NDA, IND and QC stability program support * Method development and validation * In-Vito Bioequivelance * Forced degradation studies * Final product release testing * Dosing solution analysis * Compendial testing * Comparator testing * Formulation development support * Stability storage on site
Bioanalytical Large Molecule Services include:
* Macromolecule PK/TK (hybridization and immunoassays) * Immunogenicity assays (anti-drug antibody assays) * Biomarker services for drug development (i.e. PD, safety assessment, mechanism of action) * EIA- or ELISA-based applications * Enzyme kinetic assays * Method development, validation and sample analysis of proteins, peptides and oligonucleotides"