Biotransformation & Pharmacodynamics (PK/PD) Services

Biotransformation & Pharmacodynamics (PK/PD) Services

Pharmacokinetics (PK)/Discovery Bioanalysis

Tandem Labs offers non-GLP bioanalytical services supporting early compound screening through candidate optimization and nomination. Experimental approaches are tailored to satisfy and exceed the changing assay performance characteristics that arise across the drug discovery and development continuum, while simultaneously meeting data turnaround requirements. Extensive experience in this sector has led Tandem Labs to develop a tiered service menu:

  • Initial PK screening - PK Discovery Assays Level 1
    Greater than 75% calibrations standards ≤ ± 30%
  • Candidate selection and optimization - PK Discovery Assays Level 2
    Greater than 75% calibrations standards ≤ ± 20%, ≥ 67% QC, ≤ ± 20%
  • Non-safety related IND supporting studies - PK Discovery Assays Level 3 (Good Bioanalytical Practice)
    Abbreviated assay validation consistent with agency guidelines and ensuing application; quality controlled data.

Customized approaches beyond these are also offered to meet client-specific requirements. Tandem Labs provides these analyses across all species and sample types, including tissues, plasma, serum, and urine.

Protein-Binding Assays

Tandem Labs provides high throughput plasma-protein binding (HT PPB) assays employing rapid equilibration dialysis (RED) technology. This approach enables the swift determination of drug protein binding early in drug discovery.

Biotransformation / Bioanalysis - Drug Metabolite Profiling and Identification

In the drug discovery process, investigating the fate of an administered drug dose is critical to the potential success of drug development. Increasingly, the promising role of drug biotransformation in candidate advancement, particularly in the area of safety assessment, has been highlighted by the recently published MIST guidelines. Tandem Labs will work with clients to evaluate drug biotransformation and assist in these evaluations:

  • Metabolite profiling and identification
  • Pathway elucidation
  • Semi-quantification
  • Cross-species metabolic correlations

Pharmacodynamics (PD)/Biomarker Bioanalysis - Targeted Biomarker Assays

Targeted assays of specific biochemical molecules (e.g., small molecules, peptides, and proteins) are used to quantitatively fingerprint concentrations profiles in samples. These services, employing LC/MS/MS methodologies, may be used to evaluate a compound's potential as a surrogate marker of drug safety and/or efficacy, either discretely or in panels.

Biomarker Discovery

Applying analytical chemistry and novel bioinformatics to sample analyses presents an opportunity to quantitatively evaluate thousands of endogenous molecules as well as drug-derived metabolites. Comparative analysis of the resulting profiles may reveal potential biomarkers, including markers of drug response, toxicity and adverse events, mechanism of action, and/or markers of disease.