Maximum tolerated dose

Maximum Tolerated Dose (MTD) is a term used in pharmacology and toxicology to denote the highest amount of a drug or chemical that can be administered without causing unacceptable side-effects or toxicity. The MTD is determined through clinical trials and is an important factor in drug development and safety testing.

Definition

The Maximum Tolerated Dose is defined as the highest dose of a drug or chemical that can be given to a subject (usually an animal in preclinical trials) that does not result in a significant increase in mortality or morbidity. This dose is used as a starting point for determining the therapeutic dose in humans.

Determination

The MTD is determined through a series of dose escalation studies. These studies start with a low dose of the drug or chemical and gradually increase the dose until unacceptable side-effects or toxicity are observed. The dose immediately below this level is considered the MTD.

Use in Drug Development

In drug development, the MTD is used to establish the safety profile of a new drug. It is also used to determine the dose for Phase I clinical trials, which are the first stage of testing in humans. In these trials, the goal is to determine the drug's safety, side effects, and the body's ability to metabolize and excrete the drug.

Limitations

While the MTD is a useful tool in drug development and safety testing, it has its limitations. For one, it is based on the assumption that the dose-response relationship is linear, which is not always the case. Additionally, the MTD does not take into account long-term effects or effects that occur at doses below the MTD.

See Also

• Dose-response relationship
• Therapeutic index
• Clinical trial
• Pharmacology
• Toxicology

Maximum tolerated dose Resources
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