Services

DMPK

Our 21 CFR Part 11 compliant facility is equipped with state of the art high-throughput LC-MS/MS  and Complex Sample Processing Equipment, including Precellys Homogenizer and Automation Tools, allows us to specialize in:

  •  Method Development and Validation, GLP and Clinical (GCP) Sample Analysis,

  • Toxicokinetic (TK) and Pharmacokinetic (PK) Analysis.

  • Metabolite
    ID/Profiling in
    different species

  • In vitro ADME studies
    for IND/NDA

  • MIST

  • Drug-Drug
    Interaction Studies

  • 14C-ADME Studies

 

Assay Development

Integrated Bioanalysis provides high throughput in vitro screening of hepatocyte and microsomal models,
plasma stability, protein binding, metabolism and transporter interactions. Routine services include:

  • Protein Characterization via LC-MS/MS and Particle Size Analysis
  • Targeted Protein Quantitation
  • SMART™ Digest Peptide Mapping

  • Conformational Analysis via FT-IR

  • PK/PD Studies

  • PK Screening

  • In vitro Studies

  • Structure
    Optimization

Consulting

Integrated Bioanalysis can advise you during any step of your drug development process ranging from conception to submission. We support all stages of preclinical development and can assist you with:

  • Investigative study design and oversight

  • Discovery and lead candidate selection

  • In vitro screening

  • Chemistry (CMC, bioanalytical, formulation)

  • Assay design and preclinical animal model selection

  • Data analysis/interpretation and scientific writing

  • Due diligence

  • Proof of concept

  • Cause/effect evaluations

Integrated Bioanalysis | support@frileyconsulting.onmicrosoft.com | 970-430-6559
 

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