phase II clinical studies

https://doi.org/10.1351/goldbook.12709
Controlled clinical studies conducted in a limited number of individuals to obtain some preliminary data on the effectiveness of an investigational new drug for a particular indication or indications in patients with the disease or condition.
Note: Phase II clinical trials have two subclasses, IIa and IIb. Phase IIa trials are essentially pilot clinical trials designed to evaluate efficacy (and safety) in selected populations of patients with the disease or condition to be treated, diagnosed, or prevented. Phase IIb trials extend those of Phase IIa to well-controlled trials that evaluate the same parameters in similar patient populations.
See also: phase 0, phase I, phase III, phase IV
Source:
PAC, 2013, 85, 1725. (Glossary of terms used in medicinal chemistry. Part II (IUPAC Recommendations 2013)) on page 1746 [Terms] [Paper]
Citation: 'phase II clinical studies' in IUPAC Compendium of Chemical Terminology, 5th ed. International Union of Pure and Applied Chemistry; 2025. Online version 5.0.0, 2025. https://doi.org/10.1351/goldbook.12709 RIS BibTex EndNote
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