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

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.