Key Principles of Drug Development in Preclinical Trials
Testing for Safety and Effectiveness
Before a new drug can be tested in humans, it first goes through preclinical trials.
These trials usually involve at least two types of animals.
The goal is to see how the drug behaves in the body and if it’s harmful.
Only about 30% of drugs make it to the next stage, clinical trials, after passing these tests.
Finding the Right Dose
It’s important to figure out the right amount of the drug to use.
This includes finding the Effective Dose (ED) and the Maximum Tolerable Dose (MTD).
Sadly, only about 10-12% of drugs move forward after this stage.
Following the Rules
During preclinical trials, it’s very important to follow the Good Laboratory Practice (GLP) guidelines.
The FDA checks the data collected to make sure everything is safe and accurate before allowing the drug to move to clinical trials.
Key Principles of Drug Development in Preclinical Trials
Testing for Safety and Effectiveness
Before a new drug can be tested in humans, it first goes through preclinical trials.
These trials usually involve at least two types of animals.
The goal is to see how the drug behaves in the body and if it’s harmful.
Only about 30% of drugs make it to the next stage, clinical trials, after passing these tests.
Finding the Right Dose
It’s important to figure out the right amount of the drug to use.
This includes finding the Effective Dose (ED) and the Maximum Tolerable Dose (MTD).
Sadly, only about 10-12% of drugs move forward after this stage.
Following the Rules
During preclinical trials, it’s very important to follow the Good Laboratory Practice (GLP) guidelines.
The FDA checks the data collected to make sure everything is safe and accurate before allowing the drug to move to clinical trials.