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What is the goal of determining the 1st Human dose of a drug?
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?
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?
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?
What does the Quality aspect of ICH guidelines aim to ensure?
What is the significance of the 1% success rate mentioned in the text?
What is the significance of the 1% success rate mentioned in the text?
What is the minimum point at which a drug shows efficacy?
What is the minimum point at which a drug shows efficacy?
What is the goal when determining the first human dose of a drug?
What is the goal when determining the first human dose of a drug?
What does the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) focus on regarding safety?
What does the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) focus on regarding safety?
What does the term 'Multidisciplinary' refer to in the context of ICH-QSEM guidelines?
What does the term 'Multidisciplinary' refer to in the context of ICH-QSEM guidelines?
What is the significance of the 1% success rate mentioned in the text?
What is the significance of the 1% success rate mentioned in the text?
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