What are the steps in drug development?

What are the steps in drug development?

Information For

• Step 1: Discovery and Development.
• Step 2: Preclinical Research.
• Step 3: Clinical Research.
• Step 4: FDA Drug Review.
• Step 5: FDA Post-Market Drug Safety Monitoring.

What are the different stages of drug development?

Preclinical research is a basic preliminary phase that involves testing the drug on animals and basic testing for safety flags. Clinical research can be one of the most important steps in a drug’s development. If a drug is cleared from preclinical trials, it moves on to clinical testing which involves human trials.

What are the phases of drug approval?

Phase 1 studies (typically involve 20 to 80 people). Phase 2 studies (typically involve a few dozen to about 300 people). Phase 3 studies (typically involve several hundred to about 3,000 people). The pre-NDA period, just before a new drug application (NDA) is submitted.

What are the three types of investigational new drugs?

The majority of INDs are filed for non-commercial research and are of three main types: Investigator IND, Emergency Use IND, and Treatment IND.

Why is FDA approval so expensive?

Excessive regulatory oversight creates an elongated and expensive route to approval. By one estimate, an approved gene therapy drug costs nearly $5 billion (five times as high as the average cost of FDA approval).

What’s the first stage of drug testing?

Phase 0 trials are the first clinical trials done among people. They aim to learn how a drug is processed in the body and how it affects the body. In these trials, a very small dose of a drug is given to about 10 to 15 people.

What are the three phases of a clinical drug trial?

Clinical trials follow a rigorous series from early, small-scale, Phase 1 studies to late-stage, large scale, Phase 3 studies. If a treatment is successful in one phase, it moves on to the next phase.

What is the clinical trial process?

A clinical trial is a research study conducted in human beings with the goal of answering specific questions about new therapies, vaccines or diagnostic procedures, or new ways of using known treatments. Clinical trials are used to determine whether new drugs, diagnostics or treatments are both safe and effective.