ADME / DMPK Services

ADME represents the lifecycle of what happens to a drug once it has been administered. In context of drug development, ADME refers to the suite of tests to assess Absorption, Distribution, Metabolism, and Excretion. 

Developing a potential drug candidate is an iterative process that requires careful planning to reach clinical trials. Most new drug candidates fail during preclinical and clinical development, and identifying those with promising ADME and pharmacokinetics properties during the discovery stage can streamline the development process. Preclinical ADME screening, drug metabolism, and pharmacokinetics assessments focus effort on potentially viable drug candidates, guiding decision-making from early discovery to Investigational New Drug (IND) filing and beyond. 

As an industry leader of clinical trial laboratory services, IQVIA Laboratories can help you make informed development decisions about your small and large molecule drug candidates by offering an array of high-throughput ADME screening and Drug Metabolism and Pharmacokinetics (DMPK) services that use validated bioanalytical methods to support candidate identification and characterization. Our ADME scientists have extensive expertise with high-throughput discovery bioanalysis and LC-MS bioanalysis platforms that enable various aspects of ADME testing and pharmacokinetic (PK) testing. From in vitro ADME screening assays and drug-drug interaction risk assessment to metabolite identification of in vitro and in vivo samples, IQVIA Laboratories services facilitate rapid drug discovery ADME property optimization and regulatory filings.

In vitro screening plays a critical role in drug candidate optimization of ADME properties. Identifying the most promising drug candidates upfront accelerates the development cycle, reduces costs, streamlines the drug discovery pipeline, and guides subsequent pre-clinical and clinical studies. IQVIA Laboratories highly automated in vitro ADME laboratory offers a range of high-throughput ADME screening services to support the lead optimization stage of drug discovery, including assays for metabolic stability, cell permeability, and risk assessment for inhibiting cytochrome P450 enzymes.

To learn more about how IQVIA Laboratories ADME screening bundles and LC-MS bioanalytical capabilities can support your in vitro and pharmacokinetic (PK) testing please visit the links below:

• Early Hit-to-Lead ADME Screening Bundle

• High Throughput ADME Services

The ADME assay development pipeline includes in vitro ADME assays that are necessary once a lead candidate has been selected. The safety profile of a drug candidate will depend partly on its interactions with other drugs, especially those that may be administered concomitantly in standard-of-care treatment. Assessing the risks of possible drug-interactions using validated bioanalytical methods is thus an essential early step in the candidate development process. IQVIA Laboratories offers a suite of in vitro assays to support drug-drug interaction testing, including cytochrome P450 (CYP) enzyme inhibition (IC50), time-dependent CYP inhibition, induction of CYP enzymes, and CYP reaction phenotyping. All in vitro metabolism assay results are presented in fully QC-reviewed, regulatory-style reports to support filing of IND applications.

To learn more about how IQVIA Laboratories in vitro assay bundle can inform your drug-drug interaction testing efforts, please follow the link below:

• Assessing drug-drug interaction risks

Assessing a drug candidate’s metabolic profile early in the discovery process offers insight into its metabolic clearance pathways in both pre-clinical species and humans. IQVIA Laboratories global bioanalytical and ADME laboratory network offers a range of liquid chromatography/ mass spectrometry services to support discovery and development metabolite identification and profiling.

Specific capabilities using high-resolution mass spectrometry (HRMS) include:

• Metabolite profiling and identification using liver microsomes or hepatocytes, as well as novel hepatocyte co-culture models for profiling slowly metabolized drug candidates
• Exploratory profiling using unlabeled drug in preclinical and human clinical samples
• Radio-profiling of both preclinical and human clinical samples
• Reactive intermediate screens evaluating glutathione/cyanide trapping drug candidates (microsomes)
  
  

To explore how IQVIA Laboratories can partner to characterize metabolites in your study, please follow the link below:

• ADME Assays & Metabolite Profiling