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The Drug Development and Approval Process.  

Cheryl Iverson

in AMA Manual of Style: A Guide for Authors and Editors (11 ed.)

Print Publication Year: 
Feb 2020
Published Online: 
Feb 2020
Item type: 
This brief summary of the drug development process is provided to help define the origins of different names used to identify drugs. Drugs intended for clinical use undergo several phases of development before they can be considered for human use. Animal studies are performed initially to assess pharmacologic and toxicologic effects. While clinical studies are being conducted, animal studies may continue to assess effects on reproduction, teratogenicity, and carcinogenicity....