I'm currently working on an in vivo project involving Sprague Dawley rats to determine the anti-obesity effect of a plant extract. The plant extract that will be fed to the rats has established safety profiles from a number of studies with OECD guidelines. Is it necessary for an acute toxicity test to be proposed animal in ethics application purposes? If it's not needed how do I justify an alternative method to the animal ethic committee if my rats happen to show signs of toxicity, death, and abnormalities throughout the study?
Thank you so much.
1. Probably, you have seen efficacy of your plant extract as a drug and want to move further.
2. I can't understand clearly what you have written. How you have already tested your extract for safety as per OECD guidline, when you have not received animal ethics approval? This would have been done before using any animals.
3. Again the same thing, how would you perform acute toxicity tests before getting animal approval?
4. If your extract is showing death and abnormalities at all doses tested, and even at efficacy doses, it can't be a drug. For risk assessment of a drug it should be more efficacious, although some adverse effects are acceptable, depending on class of drug.
5. There are no alternative methods for anti-obesity drugs which you could use to gain approval from regulatory agencies. You need to perform animal studies. Alternative methods are fine for cosmetics etc.
- Badges
- Science topic
- Similar topics
- Biological Science
- Botany
- Pharmaceutical Botany
- Plant Extracts