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Preclinical IND-Enabling Services

Human Health

Preclinical IND-Enabling Toxicology Services at MRIGlobal 

The toxicologists with MRIGlobal have experience in Investigational New Drug (IND) studies and preclinical studies, ensuring safe pharmaceuticals and the best data for your device FDA submission.

Range of IND-Enabling Toxicology Services

Our experience and in-depth knowledge of toxicology services and FDA submissions grant us the ability to conduct a wide variety of studies and project work. Our toxicology and PK studies are applicable in various small and large animal species and various administration routes. 

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.

Choose MRIGlobal for preclinical IND-enabling toxicology services

Contact MRIGlobal and get started with preclinical IND-enabling toxicology services. 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 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.

Project Quote Tool

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