Briefly describe the activities that occur in each step of the drug discovery and development process (i.e. preclinical, clinical, NDA review, post-marketing). What is the purpose of the IND and the NDA and when are they filed with the FDA?

Introduction to General, Organic and Biochemistry
11th Edition
ISBN:9781285869759
Author:Frederick A. Bettelheim, William H. Brown, Mary K. Campbell, Shawn O. Farrell, Omar Torres
Publisher:Frederick A. Bettelheim, William H. Brown, Mary K. Campbell, Shawn O. Farrell, Omar Torres
Chapter21: Lipids
Section: Chapter Questions
Problem 21.78P
icon
Related questions
Question

Briefly describe the activities that occur in each step of the drug discovery and development process (i.e. preclinical, clinical, NDA review, post-marketing). What is the purpose of the IND and the NDA and when are they filed with the FDA?

 

Expert Solution
steps

Step by step

Solved in 3 steps

Blurred answer
Knowledge Booster
Colloids
Learn more about
Need a deep-dive on the concept behind this application? Look no further. Learn more about this topic, chemistry and related others by exploring similar questions and additional content below.
Similar questions
  • SEE MORE QUESTIONS
Recommended textbooks for you
Introduction to General, Organic and Biochemistry
Introduction to General, Organic and Biochemistry
Chemistry
ISBN:
9781285869759
Author:
Frederick A. Bettelheim, William H. Brown, Mary K. Campbell, Shawn O. Farrell, Omar Torres
Publisher:
Cengage Learning
Principles of Modern Chemistry
Principles of Modern Chemistry
Chemistry
ISBN:
9781305079113
Author:
David W. Oxtoby, H. Pat Gillis, Laurie J. Butler
Publisher:
Cengage Learning
Macroscale and Microscale Organic Experiments
Macroscale and Microscale Organic Experiments
Chemistry
ISBN:
9781305577190
Author:
Kenneth L. Williamson, Katherine M. Masters
Publisher:
Brooks Cole
Chemistry In Focus
Chemistry In Focus
Chemistry
ISBN:
9781337399692
Author:
Tro, Nivaldo J.
Publisher:
Cengage Learning,
Organic Chemistry
Organic Chemistry
Chemistry
ISBN:
9781305580350
Author:
William H. Brown, Brent L. Iverson, Eric Anslyn, Christopher S. Foote
Publisher:
Cengage Learning