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CRO Toxicology IND-Enabling Services

Trusted CRO Toxicology, IND-Enabling Services, and Preclinical Studies

The expert scientists at MRIGlobal make our contract research organization’s (CRO’s) toxicology capabilities the best in the field. Toxicology provides the critical information regulatory agencies and other decision-makers use to analyze human and environmental exposure to substances in pharmaceuticals and other substances. 

MRIGlobal toxicologists are experienced in Investigational New Drug (IND) studies and preclinical studies, ensuring safe pharmaceuticals, testing devices, and the best data for your device FDA submission.

IND-enabling services with MRIGlobal

Getting your investigational new drug to the market is easiest when you partner with a CRO experienced with IND-enabling services. MRIGlobal’s extensive range of services and unmatched expertise facilitate the initiation and successful completion of your IND-enabling programs. 

We customize each study based on the type of drug, the intended administration route, and its clinical indication. These test results help the FDA determine whether the drug is safe for human (clinical) testing. 

MRIGlobal can address unexpected issues occurring during the IND phase to prevent delays in the approval timeline. 

Preclinical CRO services

As a preclinical CRO, we advance the development of new medical products by proving they are safe and effective. In a preclinical setting, the FDA requires the use of human-like models that replicate the human anatomy. 

We offer a variety of toxicology and pharmacokinetic/pharmacodynamic studies in various small and large animal species for preclinical drug development and testing to support both human and veterinary product submissions. Our preclinical administration specializations include oral, inhalation, intravenous, intraperitoneal, subcutaneous, intramuscular, intranasal, and dermal routes of administration. We are always expanding our techniques and methods and work with customers to develop the optimal study design and endpoints for their product registration package.  

Most drugs undergoing preclinical testing never make it to human testing or review by the FDA. There are steps you can take to increase your drug’s chances for success to market. Because MRIGlobal has a huge array of expertise in various scientific fields, we can test your new therapeutic and support in vivo studies with our in-house bioanalytical and dose formulation analysis services.

Like all great preclinical CROs, we carry a variety of important certifications, understand our clients’ science, and are good laboratory practice (GLP) compliant. 

Our range of IND-enabling toxicology services

Maximum Tolerated Dose (MTD) studies

Through escalating or de-escalating dose levels, we will determine the maximum tolerated or maximum feasible dose of a targeted drug or biologic.

Dose Ranging Finding (DRF) studies

  • Characterize the toxicity and pharmacokinetic (PK) profile of a target drug or biologic via any route of exposure and frequency
  • Bioanalysis and PK analysis
  • Determination of the desired dose for pivotal GLP studies

Single or Repeat dose definitive subacute and subchronic studies under GLP compliance

Evaluation of toxicity via:

  • In-life parameters including, but not limited to, clinical observations, body weight, food consumption, ophthalmology, ECG/EKG, etc.
  • Clinical Pathology (clinical chemistry and hematology parameters)
  • Histopathology Services
  • TK Profile with WinNonLin analysis/results

Testing for multiple routes of exposure

  • Oral (gavage, diet, and capsule)
  • Implant
  • Parenteral
  • Intravenous, subcutaneous, intradermal, intramuscular, and intraperitoneal
  • Intranasal/inhaled
  • Topical/Dermal
  • Ocular
  • Intravaginal and intrapenile
  • Rectal
  • Others available upon request

Bioanalytical and chemistry support

  • Method development and validation
  • Impurities isolation and identification
  • Materials characterization and release
  • Short-term and long-term stability assessment

Toxicokinetics and pharmacokinetics

Our bioanalytical capabilities include performing test article concentration analysis of blood and/or tissue samples. One of MRIGlobal’s strengths is our ability to analyze almost any type of biological matrix.  We conduct PK analysis using WinNonLin software. PK parameters include Cmax, Tmax, T1/2, AUC, etc.

Studying side effects and long-term effects of pharmaceuticals

In the United States, the Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) developed guidance on dose-response assessment. MRIGlobal works extensively with the FDA through IND applications and preclinical studies. 

A majority of toxicity testing involves dosing to achieve a certain level of toxicity or adverse effect. “We have to push the dose to understand the potential toxicity effect in human beings,” said MRIGlobal Toxicologist Brad Wahle. 

The dose-response curve

Scientists use dose-response curves to describe the dose-response relationship. Through studying dose-response, we determine the safe, hazardous, and beneficial levels and dosing of substances. The dose-response curve graph relates the magnitude of a stimulus to the body’s response. 

“Consider the curve as a measurement from no adverse effect to mortality. In our studies, we focus inside of that curve. As we move forward in each subsequent study, we become more and more focused inside the curve to find the drug’s therapeutic range,” Wahle explained. “Most great drugs have a huge therapeutic range, which makes them incredibly safe for general use. Some good drugs have a very narrow range where a small misuse could prove fatal, but the efficacious dose allows someone to live a better life.”

Choose MRIGlobal for preclinical studies

Contact MRIGlobal and get started with planning your preclinical studies. When MRIGlobal is on your side, you benefit from a trusted partnership. We are committed to getting our clients to the finish line. Your goals become our goals, and we work toward them with dedication and commitment using the scientific background and expertise only we can bring to the table.

As a not-for-profit contract research organization, we have proven ourselves as an objective partner driven to make our clients’ products more successful. We specialize in defense, human health, pharmaceutical sciences, clinical diagnostics, energy and environment, agriculture, and global health.

To learn more about the work we’ve done or how we can help you, contact us today. If you are part of an agency, business, or academic institution seeking assistance with a project, use our Project Quote Tool to get started.

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