Podcast
Questions and Answers
What is the typical duration for drug development?
What is the typical duration for drug development?
- 5-8 years
- 12-15 years (correct)
- 2-5 years
- 8-10 years
Why can experimental results from animals not be directly applied to humans?
Why can experimental results from animals not be directly applied to humans?
- Because animals and humans have similar reactions to drugs
- Because animals and humans have identical reactions to drugs
- Because some actions may not be similar between animals and humans (correct)
- Because animals are more reliable indicators of drug effects
What is the primary reason for the long and expensive journey of drug development?
What is the primary reason for the long and expensive journey of drug development?
- Regulatory barriers
- Pharmaceutical industry's inefficiency
- Lack of financial investment
- The complexity of drug development process (correct)
What percentage of drugs may reach the level of prescribing after development?
What percentage of drugs may reach the level of prescribing after development?
Why can experimental results from animals not be directly applied to humans?
Why can experimental results from animals not be directly applied to humans?
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Study Notes
Drug Development Timeline
- Typical duration for drug development ranges from 10 to 15 years.
- This extensive timeframe encompasses multiple phases, including discovery, preclinical testing, and clinical trials.
Differences Between Animal and Human Experiments
- Biological differences exist between species that may affect drug metabolism, efficacy, and safety.
- Variations in genetics, physiology, and anatomy can lead to different responses to drugs in animals versus humans.
- Ethical considerations also impact the translation of animal research to human use.
Challenges in Drug Development
- The primary reason for the lengthy and costly drug development process is the rigorous testing and regulatory approval needed to ensure safety and efficacy.
- Uncertainties in predicting clinical outcomes lead to numerous trials and modifications, contributing to high costs.
Success Rate of Drug Development
- Only about 10% of drugs in development ultimately reach the market for prescribing.
- High attrition rates occur due to failures in trials, safety concerns, or lack of effectiveness.
Reiteration on Animal vs. Human Results
- Results from animal studies often do not correlate with human outcomes due to species-specific differences.
- Comprehensive understanding of human biology is necessary to validate findings from animal research before human trials can begin.
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