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Pharmacokinetics & Toxicology

At AGI, our pharmacokinetics and toxicology services play a critical role in advancing safe and effective therapeutic development. We specialize in in vivo models that generate high-quality data on absorption, distribution, metabolism, and excretion (ADME), as well as acute and chronic toxicity profiles. Our team's deep experience in regulatory-driven studies supports preclinical programs from early dose-range finding through IND-enabling toxicology. By combining precision dosing, validated biomarkers, and robust study design, we deliver reproducible results that help clients de-risk their drug candidates and meet FDA submission requirements.

PK, TK, & PD Study Execution

We conduct full-scope pharmacokinetic, toxicokinetic, and pharmacodynamic studies to support IND-enabling and early-phase drug development across diverse therapeutic programs.

Immunotoxicology & Genetic Safety

Our immunotoxicology services evaluate immune activation, cytokine profiles, and genetic safety using high-resolution in vivo and ex vivo NHP models, supporting both exploratory and regulatory development.

Dosing Route Optimization

We test multiple dosing routes, including IV, IM, SC, PO, and IN, to define optimal delivery, biodistribution, and expression profiles in NHPs, supporting therapeutic development across diverse modalities.

GLP-Compliant & Exploratory Toxicology Studies

We conduct both GLP-compliant and exploratory toxicology studies in NHPs to evaluate safety margins, identify target organ toxicity, and support regulatory submissions and IND programs.

Organ-Specific & Targeted Toxicity Assessment

Our studies map tissue-specific toxicities in NHPs using imaging, histopathology, and biomarker profiling to characterize adverse effects and de-risk therapies before human trials.

Bioanalytical Assay Development & Validation

We develop and validate custom PK, PD, and immunogenicity assays for use in NHP studies, ensuring analytical reliability and data integrity across the entire preclinical development pipeline.

Automated Pipetting System
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