The Drug Development Process
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Questions and Answers

What is the goal of determining the 1st Human dose of a drug?

  • To keep the therapeutic dose between NOAEL and MABEL (correct)
  • To maximize the pharmacologically active dose
  • To minimize the safety factor applied to NOAEL
  • To eliminate the need for human equivalent dose calculation

    • What does the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) focus on regarding safety?

  • Uncovering risks including carcinogenicity, genotoxicity, reprotoxicity (correct)
  • Maximizing the pharmacological effect of drugs
  • Reducing the need for stability studies
  • Avoiding multidisciplinary approaches

    • What is the role of the Minimum Anticipated Biological Effect Level (MABEL) in drug development?

  • It indicates the maximum toxic level of a drug
  • It determines the human equivalent dose
  • It defines the maximum safety factor for NOAEL
  • It represents the minimum point at which a drug shows efficacy (correct)

    • What does the Quality aspect of ICH guidelines aim to ensure?

    <p>Quality through stability studies and flexible approach to pharmaceutical quality</p> Signup and view all the answers

    What is the significance of the 1% success rate mentioned in the text?

    <p>It emphasizes the importance of failing early in the development process</p> Signup and view all the answers

    What is the minimum point at which a drug shows efficacy?

    <p>Minimum Anticipated Biological Effect Level (MABEL)</p> Signup and view all the answers

    What is the goal when determining the first human dose of a drug?

    <p>To keep therapeutic dose between NOAEL and MABEL</p> Signup and view all the answers

    What does the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) focus on regarding safety?

    <p>Guidelines to uncover risks including carcinogenicity</p> Signup and view all the answers

    What does the term 'Multidisciplinary' refer to in the context of ICH-QSEM guidelines?

    <p>Cross-cutting topics such as MedDRA and CTD</p> Signup and view all the answers

    What is the significance of the 1% success rate mentioned in the text?

    <p>Serves as a threshold for toxicity</p> Signup and view all the answers

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