MTD

MTD or Maximum Tolerated Dose is a dose of a drug or chemical that is the highest that can be given without causing unacceptable side-effects. The MTD is determined during clinical trials by increasing the dose of a drug until the side-effects become too severe.

Definition

The Maximum Tolerated Dose (MTD) is defined as the highest dose of a drug or treatment that does not cause unacceptable side-effects. The MTD is determined during Phase I of clinical trials. The purpose of these trials is to find the highest dose of a new drug that can be given safely without causing severe side-effects.

Determination

The MTD is determined through a process of dose escalation, in which the dose of the drug is gradually increased until the side-effects become too severe. This process is typically carried out in a small group of patients. The dose is increased until either the maximum planned dose is reached, or the side-effects become too severe.

Use in Clinical Trials

In clinical trials, the MTD is used to determine the dose for Phase II trials. The dose used in Phase II trials is often less than the MTD, to ensure that the drug can be given safely over a longer period of time.

Criticism

Some researchers have criticized the use of the MTD in clinical trials, arguing that it does not accurately reflect the dose that will be used in clinical practice. They argue that the MTD often leads to the use of doses that are too high, and that this can lead to unnecessary side-effects.

See Also

• Clinical trial
• Dose escalation
• Phase I trial
• Phase II trial

References

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