United Pharmaceuticals Inc. provides advanced translational pharmacokinetic and pharmacodynamic research to support informed decision-making before clinical entry. Our preclinical programs are designed to clarify exposure–response relationships, refine dose selection, and guide formulation strategies ahead of first-in-human studies.
By applying a wide range of validated in vivo models, we generate meaningful insights into how drug candidates are absorbed, distributed, metabolized, and eliminated within biological systems. Real-time pharmacokinetic and pharmacodynamic data generated by our teams help optimize dosing regimens, improve therapeutic performance, and reduce late-stage development risk.
From early discovery through investigational new drug–enabling activities, our studies deliver reliable, decision-ready data to support regulatory advancement and clinical planning for both small molecules and complex biologics.
Preclinical pharmacokinetic and pharmacodynamic investigations play a critical role in early drug development by defining how a compound behaves within biological systems before human exposure. These studies support strategic program decisions by linking systemic exposure to measurable biological and therapeutic responses.
Data generated from our programs are used to guide human starting dose selection based on absorption, distribution, metabolism, and elimination findings. Exposure–response analysis supports identification of early efficacy signals and informs compound refinement when necessary. Administration routes are selected based on compound properties, therapeutic intent, and target tissue distribution.
Our team operates across strategically located preclinical facilities in North America, bringing specialized expertise to advanced therapeutic modalities including small and large molecules, monoclonal antibodies, gene and stem cell therapies, genome-editing technologies, nucleic acid–based therapeutics, and vaccine candidates.
United Pharmaceuticals Inc. designs specialized pharmacokinetic studies to support drug candidates from discovery through investigational new drug submission. These studies characterize systemic exposure and absorption, distribution, metabolism, and elimination behavior in both rodent and non-rodent models, providing essential insight into compound disposition over time.
By measuring drug concentrations at multiple time points, our teams evaluate exposure levels associated with safety and pharmacological activity. Advanced pharmacokinetic modeling and simulation approaches are applied to estimate half-life, clearance mechanisms, bioavailability, and volume of distribution. These analyses guide dose selection and dosing schedule decisions across development stages.
While pharmacokinetic studies describe how a drug moves through the body, pharmacodynamic studies evaluate how the drug interacts with biological targets to produce a response. These studies assess therapeutic activity, mechanism of action, potency, and dose–response relationships, helping bridge early discovery research with first-in-human evaluation.
Our preclinical pharmacodynamic studies utilize modern analytical tools such as biomarker analysis and advanced imaging technologies to evaluate pharmacological effects in relevant animal models. Each study is designed around the compound’s specific biological target and therapeutic indication, ensuring strong alignment with clinical objectives and translational goals.
Accurate bioanalytical support is essential for generating reliable pharmacokinetic and pharmacodynamic data throughout drug development. United Pharmaceuticals Inc. offers a fully integrated bioanalytical platform to quantify drugs, metabolites, and biomarkers across a wide range of biological matrices.
Our bioanalytical services include method development and validation, custom assay development for small molecules and biologics, and compliance with global regulatory guidelines. Quantitative analysis is performed using advanced technologies such as liquid chromatography–mass spectrometry for small molecules, ligand-binding assays for biologics and biomarkers, and polymerase chain reaction–based methods for gene and cell therapy products.
Additional capabilities include microsampling strategies, translational biomarker development, immunogenicity testing, and preparation of bioanalytical reports to support investigational new drug and clinical trial application submissions. Together, these services ensure high-quality, regulatory-ready data that support confident decision-making across preclinical programs.