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'''Dose-ranging study''' is a type of [[clinical trial]] where different doses of an investigational drug are tested to establish the dose which is both safe and effective. The main goal of a dose-ranging study is to determine the [[dose-response relationship]] of a new drug.

== Overview ==

In a dose-ranging study, multiple doses of a drug are tested in parallel to evaluate the pharmacological effect at different dose levels. This type of study is typically performed in the early phases of [[clinical development]] after initial safety of the drug has been established through [[Phase I clinical trial|Phase I trials]]. The results of dose-ranging studies are used to establish the optimal dose for subsequent [[Phase III clinical trial|Phase III trials]].

== Design ==

The design of a dose-ranging study can vary depending on the drug and disease in question. However, most dose-ranging studies are [[randomized controlled trial|randomized]], [[double-blind study|double-blind]], and [[placebo]]-controlled. Participants are randomly assigned to different dose groups, including a placebo group. The investigators and participants are blinded to the treatment assignments.

== Outcome Measures ==

The primary outcome measure in a dose-ranging study is usually a [[biomarker]] or clinical endpoint that can be measured in a relatively short time. The choice of outcome measure depends on the drug and disease in question. The dose-response relationship is then established based on the observed changes in the outcome measure across the different dose groups.

== Limitations ==

One of the main limitations of dose-ranging studies is that they are usually conducted in a relatively small number of participants and over a short period of time. Therefore, they may not detect all possible side effects of a drug, especially those that occur infrequently or over a long period of time. Furthermore, the dose-response relationship established in a dose-ranging study may not necessarily predict the long-term effectiveness or safety of the drug.

== See Also ==

* [[Clinical trial]]
* [[Phase I clinical trial]]
* [[Phase III clinical trial]]
* [[Randomized controlled trial]]
* [[Double-blind study]]
* [[Placebo]]

[[Category:Medical research]]
[[Category:Clinical trials]]
[[Category:Pharmacology]]

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Dose-ranging study - Revision history

Prab at 16:57, 22 March 2025

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