BioDuro provides integrated DMPK services that help teams evaluate absorption, distribution, metabolism, excretion, pharmacokinetic performance, PK/PD relationships, and preclinical safety throughout discovery and preclinical development. Our scientists generate decision-ready data that supports lead identification, lead optimization, candidate selection, and IND-enabling studies across small molecules, peptides, proteins, antibodies, ADCs, PDCs, PROTACs, RIBOTACs, and other advanced therapeutic modalities.

In Vitro ADME

Comprehensive and high-throughput in vitro ADME assays designed to evaluate metabolism, binding, stability, and drug interaction potential during early discovery.

• Physiochemical properties
• Chemical stability assays
• passive permeability
• Metabolic stability assays
• CYP450 inhibition and induction studies
• Plasma protein and tissue binding assays
• CYP-enzyme based and transporter-mediated interaction studies
• Rapid metabolite identification

In Vivo PK/TK Studies

Integrated pharmacokinetic and pharmacodynamic studies supporting exposure assessment, PK/PD, dose evaluation, and compound disposition analysis in target tissues.

• PK and PD biomarker studies
• Pre-formulation screening
• Dose-exposure dependent PK/PD studies
• Tissue distribution studies
• Excretion pathway analysis

Non-GLP Toxicology Services

Integrated non-GLP toxicology studies designed to support preclinical candidate selection and reduce development risk before IND-enabling studies. BioDuro’s toxicology and DMPK teams work together to evaluate safety, exposure, and species relevance, helping sponsors make informed development decisions earlier.

• Toxicology species selection based on metabolite profiling, target specificity, and sequence homology
• Toxicity study design informed by PK/PD and exposure data
• Maximum tolerated dose (MTD) studies
• Dose range finding (DRF) and toxicokinetic (TK) evaluations
• Standard in-life observations and safety assessments
• Clinical pathology including hematology, serum biochemistry, and coagulation
• Necropsy and histopathology evaluations

Bioanalytical Services

Robust bioanalytical workflows supporting quantitative bioanalysis, metabolite characterization, and pharmacokinetic evaluation across discovery programs.

• LC-MS/MS quantitative bioanalysis
• LBA based bioanalysis (ELISA, PCR, Gyrolab)
• Method development and validation
• Metabolite profiling and pathway analysis
• Structural characterization of metabolites

Advanced Modality Support

Specialized DMPK approaches supporting peptides, proteins, ADCs, oligonucleotides, and other complex therapeutic modalities where traditional models may not fully predict in vivo behavior.

• Peptide metabolism assessment
• Gastrointestinal and plasma stability models
• Soft-spot identification
• Structure–metabolism relationship analysis