Pharmacology

Pharmacology Services

BioLegacy accelerates your discovery and development programs by providing a fully integrated, end-to-end pharmacology service designed to deliver definitive efficacy data. Our deep expertise spans a vast portfolio of validated in vivo models across multiple therapeutic areas and a comprehensive range of species, from rodents to non-human primates. Our advanced, in-house bioanalytical capabilities elucidate complex pharmacokinetic and pharmacodynamic relationships. Our operational agility ensures that studies are initiated quickly and executed efficiently. Our flexibility enables everything from rapid, non-GLP efficacy screening to pivotal, GLP-compliant safety pharmacology studies required for your IND.

  • Extensive Portfolio of Validated Efficacy Models Hundreds of well-characterized and validated models across key therapeutic areas.
  • Comprehensive Multi-Species Expertise In-house capabilities for pharmacology studies in mice, rats, hamsters, guinea pigs, rabbits, canines, pigs, sheep, and non-human primates.
  • Integrated PK/PD Modeling & Bioanalysis In vivo dosing with advanced bioanalysis (LC-MS/MS, MSD, flow cytometry, etc.) to elucidate the exposure-response relationship.
  • GLP-Compliant Safety Pharmacology Full ICH S7A/B core battery assessments, including cardiovascular telemetry, respiratory, and CNS studies, conducted in a rigorous GLP environment.
  • Custom Model & Assay Development Bespoke in vivo efficacy models and novel bioanalytical assays for emerging targets.
  • Advanced Dosing & Surgical Capabilities Proficiency in a wide range of administration routes (e.g., IT, ICV, infusions) and complex surgical models to meet any study requirement.
  • Flexible & Agile Study Execution Rapid study start-up and the flexibility to adapt protocols to emerging efficacy data.
  • Deep Therapeutic Area Expertise Including oncology, immunology, neuroscience, metabolic disease, and more.

In Vivo Efficacy Models to Empower Your Studies

One of BioLegacy’s core strengths is our extensive portfolio of well-characterized in vivo efficacy models across a wide range of human diseases. Our PhD-level study directors, each an expert in their specific therapeutic area, leverage these translatable systems to help you demonstrate proof-of-concept, evaluate efficacy, and elucidate your therapeutic’s mechanism of action. By selecting the most scientifically relevant model, we ensure the generation of robust, decision-driving data that builds a strong foundation for your IND program.

  • Extensive Portfolio of Validated Efficacy Models Hundreds of well-characterized and validated models across key therapeutic areas.
  • Comprehensive Multi-Species Expertise In-house capabilities for pharmacology studies in mice, rats, hamsters, guinea pigs, rabbits, canines, pigs, sheep, and non-human primates.
  • Integrated PK/PD Modeling & Bioanalysis In vivo dosing with advanced bioanalysis (LC-MS/MS, MSD, flow cytometry, etc.) to elucidate the exposure-response relationship.
  • GLP-Compliant Safety Pharmacology Full ICH S7A/B core battery assessments, including cardiovascular telemetry, respiratory, and CNS studies, conducted in a rigorous GLP environment.
  • Custom Model & Assay Development Bespoke in vivo efficacy models and novel bioanalytical assays for emerging targets.
  • Advanced Dosing & Surgical Capabilities Proficiency in a wide range of administration routes (e.g., IT, ICV, infusions) and complex surgical models to meet any study requirement.
  • Flexible & Agile Study Execution Rapid study start-up and the flexibility to adapt protocols to emerging efficacy data.
  • Deep Therapeutic Area Expertise Including oncology, immunology, neuroscience, metabolic disease, and more.

Holistic Toxicology Study Support

A comprehensive understanding of a compound’s exposure-response relationship is critical for successful clinical translation. BioLegacy’s PK/PD studies are designed and executed to provide a clear picture of what your drug does to the body and what the body does to your drug. This essential data is used to establish therapeutic index, guide dose selection for IND-enabling or first-in-human studies, and provide the mechanistic link between drug concentration and biological effect.

  • Pharmacokinetic (PK) profiling in rodent and large animal species
  • Toxicokinetic (TK) support for GLP and non-GLP safety studies
  • Bioavailability and bioequivalence assessments
  • Integrated pharmacodynamic (PD) biomarker analysis
  • Tissue and CNS distribution studies
  • Single- and repeat-dose PK characterization

Bioanalytical & Support Services

Robust in vivo pharmacology is supported by BioLegacy’s state-of-the-art, in-house bioanalytical capabilities, ensuring seamless integration and rapid data turnaround. Our laboratories are equipped with advanced platforms to provide precise, quantitative data from a wide range of biological matrices. This allows for a deep, mechanistic understanding of your compound’s activity and provides the unimpeachable data quality you need for studies from exploratory research to regulated, IND-enabling, GLP preclinical trials.

  • LC-MS/MS for small molecule, peptide, and metabolite quantification
  • Ligand-Binding Assays (ELISA, MSD) for biologics and biomarkers
  • Multi-Color Flow Cytometry for cellular target engagement and immunophenotyping
  • Quantitative Histology & IHC for tissue-specific analysis
  • De Novo Bioanalytical Method Development & Validation
  • Formulation and Dose Analysis
  • Digital PCR and real-time PCR for gene therapies and analysis of gene expression

We just expanded!

See why BioLegacy is one of the fastest growing CROs in the United States.

  • 100s of extensively validated animal models
  • Many species, including NHPs
  • Extensive on-site bioanalytical capabilities
  • New, state-of-the-art facilities
  • Rapid study initiation - usually 2 weeks or less!
Contact us today and let’s get the data you need.