GLP and Non-GLP Toxicology

Whether you are looking for general non-GLP in vivo testing to help accelerate program viability decisions or need GLP-compliant testing for IND submissions, GD³ provides customized services that meet your study needs and budget. Preliminary, non-GLP studies can be used to make early go/no-go decisions, select IND Development Candidates, initiate mechanistic studies to understand the toxicity, and facilitate optimal dose selection for GLP studies.

Early toxicity identification in non-GLP in vivo safety studies allows for a better design of more costly and time-consuming GLP toxicology studies. In addition, information from early safety and toxicology experiments can help select the most viable development candidate or make an early go/no-go decision for the target.

Non-GLP discovery toxicology and clinical pathology services include:

• Body weight measurements
• Serum and urine clinical chemistries
• Hematological analysis of peripheral blood
• Immuno-phenotyping of peripheral blood and tissues by fluorescence-activated cell sorting (FACS)
• Tissue collection, processing and optional histological analysis
• Phenotypic characterization of genetically modified mice for target liability assessment
• Toxicity evaluation in knock-out mouse models

GD³ can also carry out GLP toxicology studies in multiple species, including mouse, rat, rabbit, dog and minipig. A good GLP Program typically includes several key elements, including:

• Standard Operating Procedures
• Comprehensive personnel training
• Consistency
• Accountability
• Study documentation and archiving
• Quality Assurance (QA) oversight and auditing
• Facilities and instrumentation maintenance and validation

Speak with our team of experts, who can evaluate your needs and properly determine which route is appropriate to save you both time and money.

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