Dear all,
I have found few articles which are addressed mainly on the possible cyto and genotoxic effects of Commercially available anticancer drugs. I am giving the title of few articles which reflects the same...For example
Tamoxifen citrate induced sperm shape abnormalities in the in vivo mouse.
Protecting effect of caffeine against vinblastine (an anticancer drug) induced genotoxicity in mice.
A comparison of the in vitro genotoxicity of anticancer drugs idarubicin and mitoxantrone.
AND MANY MORE..
My question is how one could test an anticancer drug for its toxicity in invitro and invivo conditions which has already got USFDA approval after having undergone different levels of screening procedures during the preclinical trials????
What are the implications that could be drawn on the preclinical trials if an anticancer drug which is used for the cancer treatment is proved to induce toxic side effects in normal cells even at its therapeutic dose????
Is there any need to standardise the preclinical trials in such a way that toxic effects exerted by anticancer drugs post treatment could be minimized????
Dear Sujayraj, when we talk about any anticancer drugs, they are ones with most cytotoxicty against normal cells. These drugs get approved comparing adverse effect vs health benefits. If health benefit overweigh substantially, then the drug gets approved.
Once the drug is put into market it does not mean that the research needs to be stopped because. There is always scope for improvement like
- In the case of "Protecting effect of caffeine against vinblastine (an anticancer drug) induced genotoxicity in mice" , study relates to improvement of patient condition. Such things definitely follows drugs release to the market.
- In other case, "A comparison of the in vitro genotoxicity of anticancer drugs idarubicin and mitoxantrone", the study would assist doctor to make choice of drug based on need comparing toxicities and efficacy.
Such studies usually takes places only after drug is into market. Its not feasible to do comprehensive research considering time and expertise required. If such a comprehensive studies were to be performed, many would have died waiting for the drug as none of the drugs would have.
Hope this brief explanation was helpful.
Hi Sujayraj - the reply by Vathan is all pertinent to your question and you may also like to read
http://www.nature.com/nature/journal/v483/n7391/full/483531a.html
- and also the comments this paper generated! There are many other papers out there to help you with your questions. Also, retesting - or ultimately, re-purposing - of approved drugs is a common practice in all research fields and not just Oncology. These compounds (and the many many that did not reach the clinic) are valuable tools to examine function in the particular cell type you are interested in. This way, we continue to improve our currently tiny knowledge of "how things work". The process of drug discovery today is undoubtedly flawed, but there is also a good recognition of how much work is yet ahead, which should give us hope. Good luck with yours!
Usually if you are planning to do a generic drug against a RLD, if the route of administration is same, and the API remains same, you don't need a toxicity study. However any significant changes in API ( say different salt form) would be considered as a change but still tox study can be waived ( route of administration is same) if you write to FDA. If you plan to develop a alternate route of administration then you need to do the tox study for the new dosageform.
Dear, as long as u know what kind of side effect or disadvantage of the drug or the drugs combination, u could know what kind of improvement to do in the future during ur drug development, right? The progress of drug development or other things development is base on the accumulation of the past, we can not make ur achievement without clearly understanding the success or the failure in the past, right?
That is y the marketed drug is still valuable to be investigated.
Personal views, only 4 ur reference.
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