Cancer staging test new drugs, clinical trials of anti-tumor drugs are divided into four phases:
I clinical trial: preliminary clinical pharmacology and human safety evaluation tests. Including human tolerance test and pharmacokinetic trials, provide the basis for the administration of the program. I clinical trial of a typical human body pharmacology test.
clinical trials: is drug efficacy and safety of the preliminary evaluation and recommendation for the clinical trial phase clinical dose. Typical phase clinical trial is to explore the test.
clinical trials: is to further evaluate the efficacy and safety of new drugs, is to expand the mouth of a multi-center clinical trials typically clinical trials is the validation test. clinical trials in the analysis of data obtained on the basis of; clinical trials should be verified on the target indication and the population of drug is safe, effective, and for the benefit back to the risk assessment and approved listing of some materials to provide sufficient basis for drugs while writing complete instructions for use provide the necessary information. clinical trials for this study can be related to dose – response relationship, a wider range of people, different stages of the disease, or combination therapy, long-term drug use research.
clinical trial: a post-marketing drug monitoring is widely used in clinical test under the conditions of efficacy and adverse reactions, special attention should be found in the rare adverse reactions. clinical trials are usually for the rationalization of drug use has a positive effect. clinical trial may include safety studies, drug interaction studies, epidemiological studies. Should be noted that clinical trials listing should be allowed within the licensed indications.
Staging of tumor drug test, the test stage for the premise of protecting the safety of new drug research and development step by step is very important. However, the clinical research process in different types of research purposes may sometimes not necessarily limited to "corresponding" sequence of time stages of clinical trials, such as the drug generation of dynamic tests, sometimes as the study in depth in order to answer new questions raised by required in the , trial at the same time or even continue. As background to apply for registration of drugs, different levels of maturity, a drug for which application for listing of required clinical trials, should be implemented in accordance with the provisions of the relevant regulations.