Drug approvals, process phases

Drug approval processes go through IND and NDA procedures in Japan. The MHLW of Japan has set up the Pharmaceutical and Medical Device Agency (PMDA), which provides technical consultation services for clinical trials. There are four types of consultations before IND, at the end of Phase II studies, before NDA, and consultation on individual protocols. 

The process of conducting dinical trials for drug approval may be broken down into three consecutive phases of ... 

Diet drugs that are in development take years to be approved and marketed in the United States. First, these compounds are studied in the laboratory. Then, they are tested in animals. The next step is to be tested in people. There are three rounds of study—called Phases 1,11, and III trials—to establish safety and effectiveness of the drug in humans. Drugs that are in Phase III trials are closest to approval and are usually available in the United States within a couple of years if they prove to be safe and effective. Drugs in Phase II trials are a little further behind in the approval process. 

The drug development program is divided into preclinical development, clinical development, and post-approval surveillance. Several preclinical and clinical trials are conducted during this program. In the following the phases of the clinical drug development process are described with a special focus on the data available for modeling and simulation and some objectives are exemplarily listed for the respective phases. 

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