How Drugs Are Developed and Approved

We are used to having numerous medications for all kinds of ailments. And we never stop to consider whether these drugs are safe. This is because we have the FDA which regulates and approves drugs after a long and strict process.

Pharmaceutical companies spend years and years developing and studying the drugs in various studies before their drug can find its way into the open market and to the consumers. Here’s just one well-documented example of how the process works https://www.odonate.com/tesetaxel.

The odds of a proposed medication to actually be approved for clinical trials is only 0.1%, whereas the chances of actually being approved are even slimmer, at 0.02%. So, here’s how the whole process goes and why it usually takes around 12 years.

Preclinical Trials

When a pharmaceutical company finds a chemical which has potential as a medication, they need to conduct a series of tests before any human can be given this substance.

First of all, the safety of the substance needs to be assessed, as well as having tests which confirm that the substance actually has an effect on the disease it’s targeting. This is normally done through laboratory and animal testing. Due to potential long-term problems when taking the medication, this stage lasts an average of 3 and a half years.

Apply for Investigational New Drug

In order to start human testing, the drug company needs to file for the IND. They need to include some information about the chemical composition, previous testing, as well as their plans on how to conduct human testing.

They also need to disclose any negative effects on the body, such as toxicity or side effects. The FDA responds within a month of the application submission, or it is considered void by default.

Clinical Trials Phase I

The first round of human tests is typically done on healthy humans. It consists of small groups of subjects, and it is primarily used to determine the dosage of the drug which is safe to administer, as well as how it is absorbed, how it functions and how it is metabolized. This phase typically lasts for one year.

Clinical Trials Phase II

This phase includes people who have the disease that the drug is intended to treat. These trials are bigger and include somewhere between 100 and 300 people. The aim is to establish the minimum and maximum effective doses of the drug. The average duration is around 2 years.

Clinical Trials Phase III

These trials are large and include somewhere between 1000 and 3000 people. The main aim of this phase is to identify the effectiveness of the drug, as well as the possible side effects. Apart from the known side effects from phase II, subjects are asked about their own experiences. These studies are randomized, meaning that some subjects are given the placebo, whereas others are given the real drug. Due to the importance of this stage, it lasts for 3 years.

Application for New Drug

Once Phase III is done, the drug company can apply for a New Drug status to the FDA. They need to analyze the data and submit it for control. This is a rigorous stage, and it takes up to 30 months or two and a half years.

Phase IV Studies

The final stage of drug approval is done after the drug has already reached the population. IT consists of collecting data from people who have taken the medication and analyzing it to ensure that nothing was missed during the rigorous testing.

There are ways to speed up this process, but it is rarely done to ensure that only safe medication is approved.


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