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AAALAC-accreditedUSDA-licensedOLAW-assuredPreclinical research & animal resources for global programs +1 (843) 589-5190 info@alphagenesisinc.com
Research animal retirement and lifetime care, now available through Alpha Genesis. Professionally managed lifetime care for retired research primates, with expert social reintroduction into stable outdoor groups led by veterinary staff deeply experienced in laboratory-animal medicine.
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Program · By modality
Alpha Genesis characterizes the exposure, safety and dose of a small-molecule candidate in rodent and nonhuman primate models. Pharmacokinetics, LC-MS/MS bioanalysis, toxicology and safety pharmacology are run and read together, so the exposure and safety picture holds as a single body of evidence.
A small-molecule program answers how much drug reaches the circulation, how exposure scales with dose, how the compound is cleared and metabolized, and what safety margin exists relative to the intended exposure. We design each study around those questions and quantify the compound by validated LC-MS/MS.
Pharmacokinetics, ADME-relevant characterization, metabolite profiling and safety are generated on the same molecule by one team, so exposure links directly to the pharmacodynamic and toxicology findings it needs to explain.
What this program covers
The in vivo dosing, the bioanalytical laboratory and the pathology all sit inside Alpha Genesis, so the small-molecule program is designed and delivered as a connected whole. Studies run to GLP for regulatory submission or as non-GLP work to inform internal decisions.
Single- and repeat-dose plasma pharmacokinetics across dose levels, with exposure metrics and assessment of dose proportionality and accumulation.
Exposure-response analysis linking plasma and, where relevant, tissue concentrations to pharmacodynamic and target-engagement endpoints.
Quantitation of parent compound in plasma and matrices by LC-MS/MS, with method development and validation of accuracy, precision and sensitivity.
Identification and relative quantitation of circulating metabolites to characterize biotransformation and support metabolite exposure assessment.
Early studies that establish tolerated dose levels, define the exposure range and inform cohort sizing for the definitive program.
Acute, subacute and chronic dosing across dose levels in rodent and nonhuman primate models, with recovery groups to assess reversibility.
Cardiovascular, central nervous system and respiratory evaluations, including telemetered ECG and blood-pressure endpoints.
Hematology, clinical chemistry, coagulation and urinalysis alongside histopathology read by board-certified pathologists.
Characterization in a rodent species followed by nonhuman primate work under one program, so exposure and safety data carry forward.
Where it leads
The exposure and dose-range findings set the dose levels for definitive GLP toxicology and safety pharmacology, which form the safety section that supports a first-in-human submission. When the candidate is ready to move toward the clinic, the same team carries the work into the full program.
Discuss your program
Tell us about your small-molecule candidate and the decision the data needs to support. Our scientific team will review it and follow up to discuss the study plan, including the bioanalytical method and whether GLP or non-GLP work fits the stage of your program.