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IIT Research Institute

Chicago, Illinois, US

IIT Research Institute (IITRI), provides fully accredited, GLP compliant pre-clinical toxicology, efficacy, PK and ADME evaluation services to the pharmaceutical, biotech, veterinary, agrichemical and nutraceuticals industries. Since its founding in 1936, IITRI has also taken a leading role as a full service provider of basic research for government agencies and academic researchers.

IITRI's highly skilled experts and modern facilities support a complete package of IND and NDA enabling studies for all dosage forms and all indications in nearly every species. Additionally, we offer a wide range of speciality services including:

Inhalation Studies in Rodent and Non-Rodent Species
Animal Bio-Safety Level 2 and 3 Suites for the Study of Pathogens
Efficacy Evaluations
Xenograft Models

IITRI operates more than 125,000 square feet of state-of-the-art laboratory and support space in our Chicago facility.... Show more »

IIT Research Institute (IITRI), provides fully accredited, GLP compliant pre-clinical toxicology, efficacy, PK and ADME evaluation services to the pharmaceutical, biotech, veterinary, agrichemical and nutraceuticals industries. Since its founding in 1936, IITRI has also taken a leading role as a full service provider of basic research for government agencies and academic researchers.

IITRI's highly skilled experts and modern facilities support a complete package of IND and NDA enabling studies for all dosage forms and all indications in nearly every species. Additionally, we offer a wide range of speciality services including:

Inhalation Studies in Rodent and Non-Rodent Species
Animal Bio-Safety Level 2 and 3 Suites for the Study of Pathogens
Efficacy Evaluations
Xenograft Models

IITRI operates more than 125,000 square feet of state-of-the-art laboratory and support space in our Chicago facility. IITRI-owned facilities include 48 fully AAALAC-accredited animal laboratories and inhalation suites for studies in both rodent and non-rodent species, extensive analytical chemistry laboratories and instrumentation, cell and molecular biology laboratories, microbiology laboratories, and animal bio-safety level 2 and 3 (ABSL-2/3) facilities for studies involving pathogenic agents.

IITRI recently completed an $18.8 million facility expansion to provide a broader range of services to our Sponsors. Newly established capabilities in synthetic organic and medicinal chemistry complement our broad range of experience in toxicology, safety and efficacy evaluation of drugs and new chemical entities, as well as analytical and bio-analytical chemistry services.

The IITRI research facility is a single, self contained, DOD secure facility insuring safety and security for our clients' projects, materials and data.

Accreditations:
- Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)
- United States Department of Agriculture (USDA)
- United States Drug Enforcement Agency (USDEA)
- Office of Laboratory Animal Welfare, NIH (OLAW)
- United States Centers for Disease Control (CDC)

Publication examples:
ANALYTICAL CHEMISTRY AND PHARMACOKINETICS
- Pharmacokinetics and enhanced bioavailability of candidate cancer chemopreventative agent, SR13668, in dogs and monkeys. Cancer Chemother. Pharmacol., DOI 10.1007/s00280-009-1116-4, 2009. I.M. Kapetanovic, M.Muzzio, S.-C. Hu, J.A. Crowell, R.A. Rajewski, J.L. Haslam, L.Jong, and D.L. McCormick.
- Direct quantitation of glucoraphanin in dog and rat plasma by LC-MS/MS. J. Pharm. Biomed. Anal., in press, 2010. M.J. Cwik, H. Wu, M. Muzzio, D.L. McCormick, and I. Kapetanovic.

TOXICOLOGY
- Integration of in vivo and in vitro approaches to characterize the toxicity of Antalarmin, a corticotropin-releasing hormone receptor antagonist. Toxicology, 248, 8-17 (2008). T.L. Horn, J.B. Harder, W.D. Johnson, P.T. Curry, R.E. Parchment, R.L. Morrissey, P.W. Mellick, K.A. Calis, P.W. Gold, K.C. Rice, C. Contoreggi, D.S. Charney, G. Cizza, E.R. Glaze, J.E. Tomaszewski, and D.L. McCormick.
- Subchronic oral toxicity studies of Se-methylselenocysteine, an organoselenium compound for breast cancer prevention. Food Chem. Toxicol., 46, 1068-1078 (2008). W.D. Johnson, R.L. Morrissey, I. Kapetanovic, J.A. Crowell, and D.L. McCormick.

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In vitro ADME
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IITRI's experience with the design and conduct of absorption, distribution, metabolism and excretion (ADME) studies includes:
- Using a wide variety of in vivo models, ranging from rodents to dogs to primates.
- Using in vitro techniques including static and dynamic percutaneous absorption systems with rodent and human... Show more »

IITRI's experience with the design and conduct of absorption, distribution, metabolism and excretion (ADME) studies includes:
- Using a wide variety of in vivo models, ranging from rodents to dogs to primates.
- Using in vitro techniques including static and dynamic percutaneous absorption systems with rodent and human skin.
- Using various routes of administration including inhalation, intravenous, oral and dermal.
- Evaluating the metabolism and kinetics of radio-labeled dosing formulations and determining the mass balance and tissue/organ distribution of dosing formulations.
- Identifying metabolites.
- Developing pharmacokinetic models.

IITRI also performs toxicokinetics studies, either as part of a toxicology study or stand-alone. Rodents, dogs and primates are the species used for these studies, with blood collected at 6-8 time points. We measure bioavailability as well as PK parameters such as Cmax, Tmax, AUC and half-life.

Our facility offers GLP-compliant, preclinical studies designed to investigate Absorption, Distribution, Metabolism and Excretion (ADME) to support drug discovery, safety evaluation and clinical development programs as well as supporting laboratories for the conduct of GLP-compliant pharmacokinetic and toxicokinetic studies on pharmaceuticals and biotechnology-derived products. Studies are conducted in all rodent and non-rodent species and primates with the goal of determining the time course of a drug candidate as well the major metabolites after administration of a drug. These studies are supported by IITRI Analytical Chemistry Division’s our full line of GLP Compliant Instrumentation / Equipment and immuno-assay (e.g. ELISA) analyses in biological matrices.

In addition to routine blood collection, our technologists can use specialized sampling technique to collect blood samples from individual animals without the need for anesthesia or cannulation.

Special Capabilities
· Radio-Labeled ADME Studies
· Custom-Designed PK Studies

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In vivo PK/PD Studies
Price on request

IITRI's experience with the design and conduct of absorption, distribution, metabolism and excretion (ADME) studies includes:
- Using a wide variety of in vivo models, ranging from rodents to dogs to primates.
- Using in vitro techniques including static and dynamic percutaneous absorption systems with rodent and human... Show more »

IITRI's experience with the design and conduct of absorption, distribution, metabolism and excretion (ADME) studies includes:
- Using a wide variety of in vivo models, ranging from rodents to dogs to primates.
- Using in vitro techniques including static and dynamic percutaneous absorption systems with rodent and human skin.
- Using various routes of administration including inhalation, intravenous, oral and dermal.
- Evaluating the metabolism and kinetics of radio-labeled dosing formulations and determining the mass balance and tissue/organ distribution of dosing formulations.
- Identifying metabolites.
- Developing pharmacokinetic models.

IITRI also performs toxicokinetics studies, either as part of a toxicology study or stand-alone. Rodents, dogs and primates are the species used for these studies, with blood collected at 6-8 time points. We measure bioavailability as well as PK parameters such as Cmax, Tmax, AUC and half-life.

Our facility offers GLP-compliant, preclinical studies designed to investigate Absorption, Distribution, Metabolism and Excretion (ADME) to support drug discovery, safety evaluation and clinical development programs as well as supporting laboratories for the conduct of GLP-compliant pharmacokinetic and toxicokinetic studies on pharmaceuticals and biotechnology-derived products. Studies are conducted in all rodent and non-rodent species and primates with the goal of determining the time course of a drug candidate as well the major metabolites after administration of a drug. These studies are supported by IITRI Analytical Chemistry Division’s our full line of GLP Compliant Instrumentation / Equipment and immuno-assay (e.g. ELISA) analyses in biological matrices.

In addition to routine blood collection, our technologists can use specialized sampling technique to collect blood samples from individual animals without the need for anesthesia or cannulation.

Special Capabilities
· Radio-Labeled ADME Studies
· Custom-Designed PK Studies

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Analytical Method Development
Price on request

Analytical method development services are very much sought after these days. IITRI’s Analytical Chemistry Division applies its expertise in analytical techniques to develop innovative methods using the full line of GLP Compliant Instrumentation / Equipment. Our sponsor’s needs are met by having, under one roof, a dedicated... Show more »

Analytical method development services are very much sought after these days. IITRI’s Analytical Chemistry Division applies its expertise in analytical techniques to develop innovative methods using the full line of GLP Compliant Instrumentation / Equipment. Our sponsor’s needs are met by having, under one roof, a dedicated facility and multidisciplinary knowledge base. This allows us to provide method development services using an integrated approach that ensures cost effective solutions, deliverable turnaround times and a clear focus on the requirements of the sponsor.

Our Method Development services can involve the following steps;
· Discussions with sponsor
· Evaluation of analytical performance criteria & analyte issues
· Literature review
· Review of method approach
· Modification of the method to meet performance criteria
· Conduct of mini-validation
· Compilation of draft report
· Review and approval of draft report
· Compilation and approval of final report
· Archival of final report, source data and electronic data

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Preclinical PK/PD Studies
in vivo Pharmacokinetics/Pharmacodynamics
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In vivo Pharmacokinetics at IITRI

Having early stage pharmacokinetic (PK) data to evaluate a new chemical entity is a prerequisite for a successful battery of pharmacological and toxicological animal studies. Obtaining quantitative measures of drug exposure is critical to the interpretation of preclinical efficacy studies. PK... Show more »

In vivo Pharmacokinetics at IITRI

Having early stage pharmacokinetic (PK) data to evaluate a new chemical entity is a prerequisite for a successful battery of pharmacological and toxicological animal studies. Obtaining quantitative measures of drug exposure is critical to the interpretation of preclinical efficacy studies. PK data can also assist in the design and species selection for preclinical toxicology studies. Therefore, employing the crucial information on the physicochemical properties of the test material and IITRI’s experience in animal dosing and sample collection can ensure the quality of your data. IITRI’s practices follow our in-house SOPs to obtain blood and/or tissue samples from test animals following dose administration. These samples can then be analyzed using bioanalytical methods developed at IITRI. The data obtained are used to generate concentration versus time curves and allow the determination of fundamental PK parameters.

In short, IITRI can provide a complete PK study including both the in-life portion and bioanalytical work. Our scientists can perform PK, bioavailability, bio-distribution and bio-equivalence studies for new or experimental drugs. Our staff has investigated a wide variety of small molecule drugs and protein biopharmaceuticals (biological). Standard drug efficacy testing can be performed in a variety of animal models using protocols supplied by you, or developed by us, making full use of the scope and breadth of the knowledge base available through our Toxicology, Inhalation Toxicology, Microbiology, Molecular Biology, Cancer Biology and Analytical Chemistry scientists.

Pharmacokinetic Studies
In a typical PK study, blood samples are obtained from test animals following a single dose or a timed perfusion. Plasma samples are separated and analyzed. Typically, if the drug is going to be administered orally, both an i.v. PK and an oral PK should be run. From these two studies both the bio-availability and the pharmacokinetics of the drug can be calculated. The data is also used to generate concentration vs. time curves and allow the determination of fundamental PK parameters such as Cmax, Tmax, AUC, drug clearance, terminal elimination half-life, oral bioavailability and volume of distribution.

Time Points
The time points (and hence the number of animals) depend on the compound, the route of administration, and its half-life. For a small molecule administered i.v., we would recommend a span over the first 24 hours post dosing because the half-life is short and because it is given IV. On the other hand, for a monoclonal antibody that has a half-life of several days, there is no reason to do a number of time points on Day 1. We would look at spreading the time points into several days.

Delivery Methods
IITRI's scientists are experienced with all standard delivery methods including:
- Oral
- Subcutaneous
- Intravenous
- Intramuscular
- Intraperitoneal
- Nasal Cavity
- Nasal Mucosa
- Tracheobronchial (Inhaled Aerosols)
- Continuous Infusion

Animal Species Offered
IITRI offers PK studies in the following animal species:
- Ferrets
- Hamsters
- Mice
-Rats
- Rabbits
- Dogs
- Non-Human Primates (NHP)
- Guinea Pigs

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Human Tumor Xenograft Models
Price on request

IITRI scientists use whole animal model systems to evaluate the efficacy and toxicity of potential therapeutic agents in Xenograft models. By maintaining a broad range of National Cancer Institute recommended Xenograft tumor models in-house, our clients can receive high-quality testing, which allows them to develop new therapeutic... Show more »

IITRI scientists use whole animal model systems to evaluate the efficacy and toxicity of potential therapeutic agents in Xenograft models. By maintaining a broad range of National Cancer Institute recommended Xenograft tumor models in-house, our clients can receive high-quality testing, which allows them to develop new therapeutic agents quickly, efficiently and cost effectively.

Xenograft Animal Models Available:
- Breast
- Colon
- Lung
- Kidney
- Ovarian
- Prostate
- Melanoma
- More to come

Our scientists have many years of experience conducting Xenograft studies and are available to assist in the selection of the most appropriate human Xenograft model for their specific needs. Complimentary consultations are available upon request.

We work hand in hand with our clients in designing experiments and selecting the screening methods for an investigational agent.

Depending on client needs we regularly assist in addressing the following:
- Tumor growth delay (latency, TGD)
- Tumor growth inhibition (TGI)
- IC50
- Toxicity
- Survival
- Combination approaches

Xenograft studies can be designed to identify lead compounds, optimize dose schedules, and identify combination strategies.

Current Cell Lines:
- Breast: MDA-MB-231
- Colon: COLO 205, HCT 116, HT-29, RKO
- Lung: A549, NCI-H460, NCI-H522
- Melanoma: MDA-MB-435
- Ovarian: OV-CAR-3, OV-CAR-5
- Prostrate: DU 145, PC3
- Renal: RXF393

Deliverables:
Once the Xenograft study is complete, a comprehensive report is provided in a professional format that includes methods, results, discussion, tables, graphs, raw data and statistical analyses.

Our team also has expertise to expand your study to understand the molecular mechanism of drug action using both in vitro and in vivo models. In addition, our Analytical Chemistry Division has the experience and instrumentation to assess tissue distribution and pharmacokinetics of the test agent.

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Project and Process Management
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ADME/DMPK Studies
Drug Metabolism and Pharmacokinetics
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Clinical Laboratory Services
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Experimental Design
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Oncology Animal Models
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Animal Models and Studies
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Pharmacology & Toxicology
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Histology and Pathology Services
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Assay Development
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Animal Models of Disease
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Xenograft Models
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Clinical Research
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Chemistry and Materials
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Chemistry and Materials Services

Chemistry and Materials Services

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Analytical Chemistry Services
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Analytical Chemistry Services

Analytical Chemistry Services

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