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What Are the Key Stages in the Drug Approval Process and Why Do They Matter?

Key Steps in the Drug Approval Process:

  1. Preclinical Testing:
    In this first step, scientists do tests in labs and on animals to see how a drug works and if it is safe. It's tough here—around 70% of drugs don’t make it past this stage.

  2. Investigational New Drug (IND) Application:
    Next, the drug makers submit an IND to get permission from government agencies like the FDA in the U.S. They need to provide detailed information about the tests they’ve done. Sadly, only about 10% of these drug applications go on to the next part.

  3. Clinical Trials:
    Here, the drug is tested on people in three phases:

    • Phase I: This phase checks if the drug is safe. About 20 to 100 healthy volunteers try it out. About 70% of drugs continue to Phase II.
    • Phase II: Now, the focus is on how well the drug works and how much patients should take. This phase involves 100 to 300 patients, and around 33% of drugs usually succeed here.
    • Phase III: This is the big test! It includes a lot more people—between 300 and 3,000 patients. Only about 25 to 30% of drugs reach approval after this phase.
  4. New Drug Application (NDA):
    At this point, the makers need to send in a lot of information for review. The average time for approval is about 12 months, but less than 10% of these applications get approved to be sold.

Importance:
These steps are very important to make sure that new drugs are safe and work well before they are sold to the public. This helps protect people's health and also keeps the money invested in drug research safe.

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What Are the Key Stages in the Drug Approval Process and Why Do They Matter?

Key Steps in the Drug Approval Process:

  1. Preclinical Testing:
    In this first step, scientists do tests in labs and on animals to see how a drug works and if it is safe. It's tough here—around 70% of drugs don’t make it past this stage.

  2. Investigational New Drug (IND) Application:
    Next, the drug makers submit an IND to get permission from government agencies like the FDA in the U.S. They need to provide detailed information about the tests they’ve done. Sadly, only about 10% of these drug applications go on to the next part.

  3. Clinical Trials:
    Here, the drug is tested on people in three phases:

    • Phase I: This phase checks if the drug is safe. About 20 to 100 healthy volunteers try it out. About 70% of drugs continue to Phase II.
    • Phase II: Now, the focus is on how well the drug works and how much patients should take. This phase involves 100 to 300 patients, and around 33% of drugs usually succeed here.
    • Phase III: This is the big test! It includes a lot more people—between 300 and 3,000 patients. Only about 25 to 30% of drugs reach approval after this phase.
  4. New Drug Application (NDA):
    At this point, the makers need to send in a lot of information for review. The average time for approval is about 12 months, but less than 10% of these applications get approved to be sold.

Importance:
These steps are very important to make sure that new drugs are safe and work well before they are sold to the public. This helps protect people's health and also keeps the money invested in drug research safe.

Related articles