Question

Briefly explain the various steps of developing a new drug.

(Answer with much detail)

Answer 1

The various steps required in order to develop a new drug includes:-

1. Discovery phase

This phase involves the use of experimenting with different compounds and their chemical structures in order to arrive at a new formula, which can be based upon the implementation of another drug.

2. Pre-clinical Investigation

This phase involves testing the drug implementation on rodents in order to be able to extrapolate the data to human use. This also includes testing the drug for toxicity, reproductive function effects and also teratogenicity.

3. FDA approval and Notice of claim

This phase involves the collection of three phases of clinical drug trials and testing in order to be approved by the FDA. these phases are:-

1. Selecting healthy volunteer, establishing dosage limitation, observation for safety and taking the pharmacokinetic data.

2. Selecting diseased volunteers, examining safety and efficacy.

3. Mass trial which involves a large number of volunteers, using actual use conditions, this includes reporting about the toxicity and dosing schedule and efficacy.

4. Phase 4

Permission is given from FDA in order to produce and the market the drug.