Studies On Post-marketing Drug Assessment

Post-marketing drugs have limited information on their safety and efficacy and the variety of serious adverse reactions are often occurred. In order to rational drug use, post-marketing assessment must be implemented in large population based on clinical medicine, pharmacoepidemiology, pharmacology, pharmacogenetics, pharmaeconomics, and drug policy. Many countries around the world pay more attention to post-marketing drug assessment and have established post-marketing drug monitoring system and reevaluation system. Although FDA and EMEA make great efforts to manage risk of post-marketing drug and have some experience, there is no theory to guide reevaluation. Post-marketing drug assessment is now onset in our country, and the research is unsubstantial. Establishment of assessing model suitable to drug management is vital to settle post-marketing drugs. The methods of assessing safety and efficacy of post-marketing drugs on the respect of theory and experiment were studied and discussed in this paper, the results are as followings.firstly, the methods and models of assessing safety were explored and studied, suggesting that systematic review is very important for drug assessment. The assessment model of neural networks is set up and is used to assess the efficacy of same kinds of drugs, providing the base for regulatory affairs. Secondly, the systematic review of the association between antidepressant and breast cancer and the study on anti-diabetics assessing model are practically undertaken to test the concept of assessing methods. Assessing conclusion of drug safety was made based on the systematic analysis and valuation of the cohort and control studies previously reported. Piogliztazone clinical trial was conducted by a randomized and placebo-controlled method and the data were collected. Drug efficacy was assessed and the assessment model of neural networks for post-marketing drugs was synthesized. The data from another piogliztazone clinical trial supported this model, indicating it is feasible and practicable. This research work can be used for reference for post-marketing drug assessment in future.