European Union [EU]

Nanoparticles are tiny objects, available only as intravenous formulations, that help medicines get to difficult-to-reach cells and tissue. They can also help protect molecules and control the targeted release of medicines.

Research Ethics Committees (RECs) evaluate the ethical acceptability of research before participants can be enrolled in a study. RECs are highly regulated, neutral bodies which operate according to standard operating procedures in order to protect the health and safety of human participants of clinical trials, among other things.

There are several kinds of bias that may occur in clinical trials, including selection, measurement, and publication bias. Statistics are used in clinical trials in order to avoid or correct these biases.

Non-clinical studies can be performed at any time during the life-cycle of the product, testing the compound outside of humans. Non-clinical studies aim to identify candidate therapies with the greatest probability of success, assess safety, and build solid scientific foundations before the transition to clinical development phases.

A rigorous non-clinical programme must be completed before a medicine may be tested in humans for the first time in Phase I clincial trials.