New drug development process

The New Drug Development Process Steps from Test Tube to New Drug Application Review, [Internet]. URL http //www.fda.gov/cder/handbook/ develop, htm, accessed 7-29-2000. 

Figure 8.1 Drug development process. (Source Center for Drug Evaluation and Research. The new drug development process, in The ODER Elandbook, FDA, Rockville, MD. http //www.fda.gov/cder/handbook/develop.htm [accessed July 18, 2007].)...

For most drugs, one of the most important meetings with the FDA in the new drug development process is the end of Phase 2 meeting. This was initially directed at drugs of specific interest... 

The O in SIPOC designates the final output, or the final product, service, or information provided to the customer. For our example, the pharmaceutical team identified the following outputs associated with its new drug development process ... 

Exhibit 45.2 shows a completed SIPOC Map for the new drug development process. 

Kaitin, K. The Prescription Drug User Fee Act of 1992 and the New Drug Development Process. American Journal ofTherapeutics 4 (1997) 167-72. 

The power of pharmacophore-based drug discovery has led to the evolution of a new drug development process which, together with combinatorial chemistry, has largely replaced traditional methods. The procedure begins with identification and characterization of the pharmacophore for a specific enzyme... 

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