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SAFETY FIRST: Assessing drugs early can preclude regulatory and health issues

  • Published on September 12, 2021
  • ADME 101™
  • Drug Drug Interactions (DDI)
  • Drug Metabolism
  • Publications

A Guide to When & Why to Evaluate ADME/PK & Drug-Drug Interactions

With a thorough and well-executed development plan and proper risk assessment, pharmaceutical manufacturers can be confident about the safety of their drugs—and so can the patients who need those medicines. Failure to plan and execute a thorough preclinical program can lead to consequences that stop a drug from advancing to the clinic. One must explore each new drug candidate’s victim and perpetrator potential in order to successfully meet regulators’ expectations of drug safety testing, but sponsors planning DDI and ADME preclinical work need to be aware that there is no one-size-fits-all model for program design. 89.5% of drug candidates in preclinical development drop out along the way or fail to meet requirements for entry to clinical trials. This 26 page ebook outlines:

  • A safe drug starts with a solid plan
    • Determining risk of drug-drug interactions
    • Predicting drug pharmacokinetics
    • Custom fitting the development program to the molecule
  • Pharmacokinetics expose drug-drug interaction potential
    • ADME studies: Defining a drug’s movement
    • DDI studies: Uncovering perpetrator and victim potential
  • Preclinical studies identify risk of drug-drug interactions
    • Preliminary assays: Setting the stage
    • Evaluating risk of a metabolism-mediated DDI
    • Predicting a transporter-mediated DDI
  • A more complete picture of drug activity
    • In vitro study considerations
    • In vivo animal study considerations
    • Filling in the gaps

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