![]() ![]() An increasing challenge for regulatory affairs professionals is to assure that an integrated, coherent, and nonconflicting set of information is developed across different disciplines The magnitude of this challenge is increased by the desire for more rapid drug development and the consequent increase in assumptions that are operative at any given time. In the United States, a New Drug Application (NDA) must present apr integrated, coherent, and nonconflicting set of information both within each individual technical discipline and across all technical disciplines. Clinical sciences, 4 Human pharmacokinetics. Chemistry, manufacturing, and controls, 3. ![]() Nonclinical pharmacology and toxicology, 2. The six broadly-defined technical disciplines that comprise drug regulatory applications are: 1. Successful, rapid, and efficient drug development depends on planning, coordinating, executing, and completing development activities in multiple technical disciplines. ![]()
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May 2023
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