Pre-clinical and Clinical Studies, Pharmacovigilance, Pharmacogenomics, and Commercialization of Pharmaceutical Products
摘要
Even with the development of new technologies and understanding of pathophysiology of diseases, drug discovery is still considered as a long and tedious process comprised of different stages which eventually leads to the availability of new drugs to the entire population. Development of new drug starts with research on target identification which generally takes place during academic research. Target identification and validation lead to the synthesis of new molecules through different in silico techniques such as high-throughput screening and other molecular modeling. New molecules are then examined for possible interaction with the target molecule which leads to identification and validation of new molecule. New molecules then undergo pre-clinical and clinical studies. Pre-clinical evaluations mainly involve the assessment of the safety and efficacy of novel molecules in vitro and in vivo setup before going into the clinical phase. In the clinical phase, new drug molecules are scrutinized for their safety and efficacy in human patients. After successful clinical trials, the new drug is allowed for commercialization in the market. Clinical trials assess the safety and efficacy of new drugs in a relatively small population compared to the entire population. When a drug enters the market, a pharmacovigilance program is initiated to track and report any adverse drug reaction associated with the drug. Sometimes, certain drug does not follow the expected ADME due to variation in the genetic build of a particular population. Due to that, pharmacogenomic assessment of each patient is important to personalized medication to certain patient populations. Drug discovery is a vast process and each step has its advantages and disadvantages. Here we discuss pre-clinical and clinical studies, along with pharmacovigilance and pharmacogenomic programs. In the end, we discuss the commercialization of pharmaceutical products which is different from any other product available in the market.