Pre-clinical
In vitro (laboratory) study to determine whether, under laboratory conditions, the formulation of the product can be achieved.
Phase I
First stage of human clinical testing for safety in healthy human volunteers.
Phase II
Small scale trials to assess safety and efficacy. In additional such trials may investigate the optimal clinical dose.
Phase III
Trials in an expanded patient population to assess safety and efficacy, typically conducted at multiple sites. Also called pivotal trials.
Filed
Submitted for regulatory approval in a given territory. For example, in the US, this will be submitted to the Food and Drug Administration (FDA) and in the European Community with the European Medicines Agency (EMEA).
COPD
Chronic obstructive pulmonary disease
BPH
Benign prostatic hyperplasia
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