New anti-neoplastic drug test using in vitro model: what to be concern?

Considering the present in vitro cell culture study for new anti-neoplastic agent, several facts should be discussed. First, as already noted, the observation on the drug study is derived from abnormal transformed cells which usually passed several biomedical modification and sub-culture process. This cannot directly and totally imply the normal cells and non transformed, non sub-cultured cancerous cells. To refer for effectiveness and safety for further human study or usage must be careful.Second, in vitro model cannot include any biotransformation that might occur in vivo. Drug distribution, drug elimination and interference from other biochemical substances in human body are all not studied in the vitro test. Third, it should be noted that several new anti-neoplastic alternative are developed with advanced biomedical engineering technology [4], such as recombinant protein technology and nanopharmacology. Since the medical society still has few information on the side effect of those new substances (new recombinants, new nanomaterials, etc.). The complete study on the toxicological effect is required. For the new nano-anti-neoplastic drug, the drug in vitro might totally not reflect the actual action in human body. Since the nanomaterial is highly sensitive, it might aggregate to form larger molecule in vivo or it might interact with several substances, especially for proteins, in human body. For sure, if such scenario occur, the change in pharmacological and toxicological properties is possible. The development of new drug test system for nanomaterial – based anti-neoplastic drug is required and the test must be performed within certified nanotechnology laboratory. Fourth, it must be repeatedly noted that anti-neoplastic agent is chemical hazardous. The safety concern should be for not only the patients but also on the medical personnel who develop and perform drug test. The safety of the practitioners seems to be the forgotten issue. Finally, the new alternative