The basic timeline of FDA approval is as follows: To get a compound FDA approved, a pharmaceutical company must go through several stages of testing and evaluation, including discovery and preclinical testing, filing an Investigational New Drug (IND) application, conducting clinical trials, filing a New Drug Application (NDA), FDA review, and post-marketing surveillance. This process can take several years and require significant investment of time and resources.
Since Oxamniquine is a known drug we wouldn’t need to go through the discovery process. Where we would start would be further preclinical testing to determine the drugs therapeutic index to see if it would even be a safe antibiotic.
We would need to get a dose response curve on an effective compound so that way we could generate a therapeutic index. So maybe take the compound from NCI and create a dose response with that compound at higher concentrations.
If I could do this again I would test a different compound called praziquantel similar to Oxamniquine that has less toxicity as per this study https://pubmed.ncbi.nlm.nih.gov/12764515/#:~:text=Conclusions%3A%20Praziquantel%20was%20significantly%20more,in%20clinical%20trials%20with%20schistosomicides.
In terms of actual experimentation I would not have done anything differently.
Also, the basic steps for FDA approval are as follows: To get a compound FDA approved, a pharmaceutical company must go through several stages of testing and evaluation, including discovery and preclinical testing, filing an Investigational New Drug (IND) application, conducting clinical trials, filing a New Drug Application (NDA), FDA review, and post-marketing surveillance.
Since Oxamniquine is a known drug we wouldn’t need to go through the discovery process. Where we would start would be further preclinical testing to determine the drugs therapeutic index to see if it would even be a safe antibiotic.
What would you need to do to get Oxamniquine FDA approved and what future testing and research would be done on this medication?
The basic timeline of FDA approval is as follows: To get a compound FDA approved, a pharmaceutical company must go through several stages of testing and evaluation, including discovery and preclinical testing, filing an Investigational New Drug (IND) application, conducting clinical trials, filing a New Drug Application (NDA), FDA review, and post-marketing surveillance. This process can take several years and require significant investment of time and resources.
Since Oxamniquine is a known drug we wouldn’t need to go through the discovery process. Where we would start would be further preclinical testing to determine the drugs therapeutic index to see if it would even be a safe antibiotic.
What further kind of testing would need to occur in order to prove that Oxamniquine is a suitable antibiotic?
We would need to get a dose response curve on an effective compound so that way we could generate a therapeutic index. So maybe take the compound from NCI and create a dose response with that compound at higher concentrations.
How would you prove to the FDA the safe use of Oxamniquine and how would you differ in your experimentation if you could redo your project?
If I could do this again I would test a different compound called praziquantel similar to Oxamniquine that has less toxicity as per this study https://pubmed.ncbi.nlm.nih.gov/12764515/#:~:text=Conclusions%3A%20Praziquantel%20was%20significantly%20more,in%20clinical%20trials%20with%20schistosomicides.
In terms of actual experimentation I would not have done anything differently.
Also, the basic steps for FDA approval are as follows: To get a compound FDA approved, a pharmaceutical company must go through several stages of testing and evaluation, including discovery and preclinical testing, filing an Investigational New Drug (IND) application, conducting clinical trials, filing a New Drug Application (NDA), FDA review, and post-marketing surveillance.
Since Oxamniquine is a known drug we wouldn’t need to go through the discovery process. Where we would start would be further preclinical testing to determine the drugs therapeutic index to see if it would even be a safe antibiotic.