In Vivo ADME Testing in IBD Drug Development

In vivo ADME studies are an important part of drug development and are generally conducted with radioactive labels on drug candidates to provide quantitative information on the mass of distribution, rate of metabolism, and pathway of excretion for the drug candidate and its metabolites. Data generated from in vivo ADME studies provide more complete safety and risk information, making IBD drug candidates more eligible for clinical approval.

Our In Vivo ADME Testing Services

Ace Therapeutics is an IBD-focused preclinical contract research provider with many years of experience in in vivo ADME studies. Whether the focus is on lead optimization, candidate identification or profiling, or preparing for Investigational New Drug (IND) or New Drug Application (NDA) regulatory submissions, Ace Therapeutics' in vivo ADME services can deliver extensive support.

Whether you need a single assay or a complete ADME package, our experts will help design and implement the appropriate studies for your IBD drug and research objectives. View Ace Therapeutics' comprehensive portfolio of in vivo ADME research services.

• Radiolabeled Compound Synthesis
  Our radioisotope labeling capabilities allow synthesis of a drug compound with radioisotope 'tag' attachment at a metabolically stable site on the investigational drug used in preclinical IBD drug development.
• Radiolabeled Pharmacokinetics (PK)
  We can analyze drug concentrations in plasma or colon tissue to characterize the pharmacokinetics of IBD drugs. We provide complete PK curves for compounds.
• Excretion Balance in Rodents and Non-rodents
  We offer mass balance and biliary excretion studies to analyze radiolabeled compounds in urine, feces, exhaled gases, and necropsies of IBD animals to characterize the route and rate of drug excretion.
• Tissue Distribution/ Quantitative Whole-body Autoradiography (QWBA)
  We use QWBA, tissue dissection, and microautoradiography methods to qualitatively or quantitatively detect radiolabeled compound to elucidate drug accumulation in tissue at successive time points in whole-body or organ-specific sections of IBD animals.
• Metabolite Identification and Profiling
  Determining how many/which metabolites are formed and the percent of parent exposure (AUC) in IBD animals.
• In Vivo Plasma Protein Binding Studies
  Measuring free drug concentration (unbound to proteins) in plasma of IBD animals following administration of radiolabeled or unlabeled drug compound.

Why Choose Us

• Our cross-functional group of experienced scientists covers all aspects of ADME, from drug discovery to regulatory submissions.
• We offer isotopes including ³H, ¹⁴C, ³²P, ³⁵S, ¹²⁵I, with other isotopes available upon request.
• We provide comprehensive support for radiolabeled ADME studies in non-clinical species.
• Data delivery meets all requirements and covers rapid data upload to regulatory reporting during the ADME cycle.

Ace Therapeutics offers a suite of in vivo ADME services in IBD drug development. We work closely with our clients to guide them through the entire process, delivering high quality data in a timely manner while streamlining and accelerating project decision-making. Contact us to start your drug's journey through in vivo ADME.