FAQs
1. How long does it typically take to develop a new disease model?
The time required to develop a new disease model varies widely depending on the disease’s complexity and the specific research question. Simpler in vitro or in silico models may take a few months, while complex in vivo animal models can take several years, especially if genetic engineering or extensive validation is involved.
2. How do regulatory bodies view data from disease models in the drug approval process?
Regulatory bodies, like the FDA, are increasingly recognizing the value of advanced disease models, especially human-relevant in vitro and in silico models, as they can reduce reliance on animal testing and accelerate drug development. However, these models typically serve as supporting evidence rather than replacing human clinical trials.
3. Can disease models predict rare diseases, and what are the challenges?
Yes, disease models can be developed for rare diseases, but it’s often more challenging, primarily due to the scarcity of patient data and biological samples, which are crucial for developing and validating robust models. Collaboration and shared resources are key to progress in this field.
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