New anti-neoplastic drug test using in vitro model: what to be concern?
Hainan Medical University, Hainan, China
Joseph Ayobabalola University, Abuja, Nigeria
Faculty of Medicine, University of Nis, Nis, Serbia
Wiwanitkit House, Bangkhaae, Bangkok, Thailand
DARU Journal of Pharmaceutical Sciences 2012, 20:65 doi:10.1186/2008-2231-20-65Published: 24 October 2012
First paragraph (this article has no abstract)
An important medical disorder that is common but not successfully managed in the present day is cancer. In fact, cancer has been known in medicine for many centuries. Continuous attempt to find anti-neoplastic drug leads to several ant-cancer drugs at present. However, as noted, the actual effective drug is still not available. Hence, cancer is still a deadly disease. Finding for new anti-neoplastic drug is the focus in cancer research at present. In the process, after developing of new drug alternatives, the next step is to study on its efficacy. Basically, the evaluation on pharmacological and toxicological effects has to be done for confirming the effectiveness and safety of the new drug. To serve this purpose, the in vitro model study is generally gone as the pioneer step. It is also the basic requirement for further drug registration . Focusing on the vitro model study, there are some facts to be addressed. First, the model is not an actual thing. It is only the attempt to simulate the real phenomenon. Second, the study is generally in vitro. This is for the safety reason. In vitro study means the experiment outsides the living things. Hence, an in vitro study is totally not the real case in human beings. In general, the better study can be done based on in vivo study only if the safety is completely confirmed. It should be further noted that in vivo study can also be either in animal model or real human subjects. The best interpretation has to be based on finding for human study. Nevertheless, the human study has the highest risk comparing to the other techniques. Focusing on the new anti-neoplastic drug, it is perceived as a dangerous chemical agent. Hence, it is rarely studied in human subjects. Also, it is very hard to include cancerous patients to enroll in such study and it should be unethical to perform such experiment in normal subjects. Furthermore, any studies have to follow the good research guideline. The use of randomized control trial is usually preferable for final acceptance on registration process . Finally, the present in vitro model study also poses the pitfall. Most in vitro model for the novel anti-neoplastic drug test is based on the cell culture, which is usually transformed neoplastic cell type . Those transformed cell is not normal physiological cells, hence, the normal physiological response to the studied chemical agent cannot be expected. Those cancerous cells might not respond well or tolerate to side effect .