Pharmaceutical Research and Development
(Human and Veterinary)

MRI can assist your organization in moving its new drug products through the complex registration process.

Areas of Expertise

• Bulk drug characterization
• Preformulation and formulation development
• Stability testing
• Acute and subchronic toxicology studies
• ADME studies
• Metabolite identification
• Bioavailability/bioequivalency studies
• Bioanalytical chemistry
• Analytical method development and validation
• Clinical trials

Quality assurance at MRI is designed to ensure that work meets both
client-specific QA and federal regulations.

Bulk Drug Characterization

Contact:

Thomas Grant,
Ph.D.
Director, Business Development
(816) 360-5328

MRI chemists perform a wide range of analyses to obtain identity, purity, and stability data for new drug substances and formulations, including:

• Structural identity and confirmation
• Certificates of analyses
• Purity determinations
• Stability-indicating methods development and validation
• Identification and quantitation of impurities
• Residual solvent analyses

Prototype Formulation Development

Prototype formulations can be developed for a variety of dosage forms to allow nonclinical evaluation of absorption, stability, release, etc., and to support ADME and toxicology studies.

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Preformulation and Formulation Development

Full preformulation capabilities are available for bulk drug substances including, but not limited to:

• Physical/chemical characterization
• Solid/solution stability
• Intrinsic dissolution
• Polymorphism
• Excipient, packaging, and processing component compatibility studies

Nonclinical Safety Studies

MRI performs a variety of studies, including acute and subchronic toxicity, ADME, pharmacokinetic, and toxicokinetic studies. Routes of administration include intravenous (long-term and bolus), dermal, intramuscular, subcutaneous, intraperitoneal, and oral (to specific portions of the GI tract as necessary).

Bioanalysis

Our extensive experience covers developing and validating methods for low and sub-nanogram amounts of drugs and/or biotransformation products in plasma, urine, and a variety of other tissues. MRI routinely develops and validates specific analytical methods for the measurement of candidate drugs and metabolites in biological matrices, using a comprehensive range of chromatographic and mass spectrometric methods.

We also develop immunoassay methods, such as RIA and ELISA, and can prepare novel antibodies for such methods. Method validation studies include evaluation of the following parameters:

• Accuracy
• Linearity
• Ruggedness
• Precision
• Specificity
• Limit of quantitation

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Clinical Trials

MRI conducts Phase I trials either on-site or in collaboration with other clinical
research sites. Studies may be conducted with radiolabeled or mass labeled drugs, if necessary. We routinely provide support for Phase II through IV trials conducted by clinical contract research organizations.

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Quality Assurance

Quality assurance at MRI is designed to ensure that project work meets both client-specific QA and federal regulations such as FDA current good manufacturing practices (cGMP), FDA good clinical practices (GCP), or FDA or EPA good laboratory practices (GLP). We provide quality research for federal, state, and industrial clients. Data generated can be prepared in formats that are suitable for submission to the FDA and EPA.

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