Avoid delays by getting method development and validation right from the start

Method development and validation of drug development are essential to deciding how quickly and efficiently a project moves forward. Our experienced team has industry-leading timelines for initiating method development to add speed and confidence to your program. Throughout your program, you’ll have access to a knowledgeable team that will provide you with the expertise and execution to successfully scale from discovery through late-stage clinical.

We will work with you to diligently identify gaps and provide recommendations for the strategy and execution of your bioanalytical method development and validation—we want to ensure that you are confident with your program and avoid delays.

Once Aliri has completed discovery and your drug candidate is selected, we will partner with you in method development and validation to quickly evolve your project with precision and flexibility. Robust methods are of the utmost importance, so we work through this stage quickly and precisely to get you the data you need without compromising quality.

Trusting your method development and validation project at Aliri grants you access to:

  • Effective program cost management
  • Same project team and seasoned network of technical experts
  • Time gains with reference material, project milestones, etc.
  • Productivity gains due to familiarity with analyte and compound
  • Quality excellence for all international guidelines (including recent M10 guidelines)
  • A robust list of non-proprietary assays (NPAs)—Discover if we have the NPA you need

To file your IND with precision and speed, here is how we will support your project:

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Study types

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  • PK/TK
  • Bioavailability
  • Efficacy Biomarker
  • Drug-drug interaction
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Matrices

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  • Plasma/Serum
    & blood similar
  • Gut slurry/Feces
  • Urine
  • Various Tissues (brain, lung, liver, kidney, cornea, optic nerve, umbilical cord, spinal cord, ocular, skin, muscle, other)
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Parameters of method development

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  • Specificity
  • Limit of detection
  • Limit of quantification
  • Linearity
  • Accuracy
  • Range
  • Precision
  • Stability

Ready to discuss your method development and validation strategy?