How do you evaluate the potential risks and benefits of a new drug before moving to clinical trials?

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Sample interview questions: How do you evaluate the potential risks and benefits of a new drug before moving to clinical trials?

Sample answer:

Preclinical Evaluation of Drug Safety and Efficacy

In vitro studies:

  • Cell-based assays: Assess drug effects on cell growth, viability, and function.
  • Biochemical assays: Measure drug binding affinity, enzyme inhibition, and receptor modulation.
  • High-throughput screening: Evaluate multiple drug candidates simultaneously for desired properties.

In vivo studies (animal models):

  • Pharmacokinetic studies: Determine drug absorption, distribution, metabolism, and excretion.
  • Toxicology studies: Evaluate potential adverse effects on organs, tissues, and overall health.
  • Efficacy studies: Assess drug activity against disease models, including dose-response relationships and duration of action.
  • Safety pharmacology studies: Evaluate potential effects on cardiovascular, respiratory, and other physiological systems.

Integration and analysis:

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