What are the major steps in the process of drug discovery?

There are four major steps in the drug discovery process: early drug discovery, pre-clinical phase, clinical phase, and regulatory approval. 

Phase 1: Early drug discovery

The early drug discovery phase uses many varying actions and tests, with researchers collaborating to identify and optimize prospected leads to a specific target. 

Phase 2: Pre-clinical trial

In this phase, identified substances from phase 1 are tested and optimized in a laboratory setting and in other relevant formats. 

Phase 3: Clinical trial

There are four phases of a clinical trial, I-IV. 

• Phase 1:Small groups of healthy subjects will be used to study the tolerance and safety of the drug candidate, aiming to answer three questions:

1. Is the drug safe?

2. What doses can be administered without side effects?

3. How does the substance behave in the body?

• Phase 2: This phase gets further subdivided into 2 stages, using a slightly large group of patients, typically between 100 - 500 adult patients:

  • Phase 2a: Therapy concept is checked

  • Phase 2b: The aim is to find the right dose

• Phase 3: Doctors test the drug on large groups of people to assess the effectiveness across many different patients. These tests not only confirm efficacy across a statistically significant group but also indicate potential interactions with other drugs. 

Phase 4: Regulatory approval

After completing clinical trials, data can then be aggregated, analyzed, and submitted to authorities as appropriate. Prior to sale and consumption, drugs require approval from a suitable regulatory authority.