What is your approach to ensuring the safety and efficacy of pharmaceutical excipients used in formulations?

Sample interview questions: What is your approach to ensuring the safety and efficacy of pharmaceutical excipients used in formulations?

Sample answer:

Approach to Ensuring Safety and Efficacy of Pharmaceutical Excipients:

  • Rigorous Ingredient Selection and Characterization:

    • Conduct thorough evaluations of excipients from reputable sources to assess their chemical, physical, and biological properties.
    • Characterize excipients using advanced analytical techniques to ensure compliance with regulatory standards and internal specifications.
  • Compatibility Testing:

    • Assess compatibility between excipients and active pharmaceutical ingredients (APIs) to identify potential interactions or stability issues.
    • Conduct extensive studies to predict excipient behavior under various storage conditions and processing parameters.
  • Toxicity Evaluation:

    • Conduct comprehensive safety studies to evaluate potential toxicity of excipients using in vitro and in vivo models.
    • Assess acute, subchronic, and chronic toxicity profiles to ensure safety for intended use.
  • Regulatory Compliance:

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