IITRI Performs Bioanalytical Testing Services
to Support All Phases of Drug Development

IITRI offers a broad array of bioanalytical testing services to support Investigational New Drug (IND) and other regulatory submissions. We take pride in our ability to customize our approach to meet individual customer needs. From initial dose formulation analysis to biochemical end point determination, we use a solid, scientific approach to identify problems, find solutions and meet your timelines.

Testing Services

IITRI has over 20 years of experience in the analysis of drugs from biological matrices to support pre-clinical toxicology studies in various animal models. As required by Sponsors with sophisticated analytical needs, we can contribute both to project planning as well as its execution.

Our experts assess the most effective way to obtain the specific data you request, and can provide consultation to help you develop the best study design for your objectives. We offer the following bioanalytical testing services:

• Dose formulation analysis, including determination of stability and homogeneity
• Analysis of drug concentration in plasma, tissues and excreta to characterize agent pharmacokinetics, toxicokinetics and bioavailability
• Isolation and identification of metabolites
• ADME (absorption, distribution, metabolism and excretion) studies
• Analysis of the induction/inhibition of CYP (cytochrome P450) isozymes
• In vitro metabolism studies using hepatocytes, microsomes and S9-fractions
• Determination of plasma-protein binding for in vitro and in vivo studies
• Investigation of biochemical mechanisms of action
• Determination of drug-drug interactions
• Pharmacokinetic modeling of clinical data
• Determination of in vitro percutaneous absorption
• CYP reaction phenotyping
• Tissue distribution
• Absorption models (Caco-2 cells, evert gut sac)
• Organ perfusion
• Biliary excretion
• Radiolabelled pharmacokinetic/metabolism studies

Sample Preparation

IITRI's test article preparation laboratory is as well organized, efficient and well equipped as any you'll find in the industry. Our technicians are highly trained and experienced in preparing complex formulations for pre-clinical toxicology studies; their results are consistently reliable, as demonstrated by numerous third-party analyses of dosing formulations prepared at IITRI. Our technicians prepare formulations for use in a broad range of toxicology studies:

• Solutions or suspensions for oral, dermal, and parenteral administration
• Solids
• Test Diets

In addition, the IITRI staff includes two Ph.D.-level aerosol scientists whose expertise includes the generation of test atmospheres (aerosols and vapors) for use in inhalation studies.

Method Development and Validation

IITRI is experienced in developing and validating test methods that meet U.S. and international regulatory guidelines. Our chemists are equally competent in both method development and transfer. Depending on your needs, we can build on information you provide or start with nothing more than a vial of your reference standard. We can:

• Implement your validated method in our laboratory.
• Customize our pre-existing method to meet your current need.
• Apply a literature-based method to your particular project.
• Develop a new method to meet your specific objective.

Instrumentation

Employing analytical techniques in our GLP facility, IITRI's chemists analyze small-molecule drugs and hormones, as well as large bio-molecules such as proteins. Our specialized instruments enable us to perform the following types of analysis:

• LC/MS/MS
• HPLC with a wide array of detection techniques
• Photodiode array
• Fluorescence
• Electrochemical
• In-line radio chemical detection
• UV-Vis
• Gas chromatography with FID, NPD and TCD detection
• Spectrophotometric analysis
• Radioimmunoassay

Suite of Services

IITRI offers bioanalytical testing services to support all phases of drug development. Our group can also help you design protocols and interpret data.

Please visit our Research Services web page or contact us at LSGInfo@IITRI.org for more information on the studies we perform.