Question

Question 2

You are a consultant for the FDA and have been asked to evaluate a New Drug Application. The executive summary claims the new drug is superior to existing therapies in three ways:

1. New drug is equally efficacious but more potent
2. Existing drugs are subject to approximately 50% loss due to first pass metabolism. The new drug is not affected by first pass metabolism (You may assume equal absorption)
3. The existing drugs have half-lives of approximately four hours. The half-life for the new drug is 24 hours.

Part I: Draw a graph for each of the above points that summarizes experiments supporting the claims being made. Clearly label the new drug and old drug on each graph.

Part II: The application claims that the new drug will allow for once a day dosing and have reduced side effects. In your opinion, do the data support this conclusion? Why or why not?

Answer 1

Answer:

Evaluation of New Drug Application

Part I:

Through below graph we can understand the efficacy profile of new and existing drug

Part II:

The proposed new drug as per application has got serum level concentration is better than the existing one hence it get elute out at a rate of 24 hours from the body thus maintaining the Cmax level all time better in blood plasma than the existing drug hence allow a dose as OD or once in a day. This dose also be helpful in minimising the intake of dosage forms in the body by which total impurities will be less in the single dosage form as compared to the existing drug many times consumption in a day to treat the ailment thereby reduce the side effect.

Hence new drug can be a breakthrough and helpful in treating the concerned ailment in a better and efficacious way.