Technically Feasible refers solely to technical or operational concerns, rather than economic, space, or site considerations.
Biologically-based mental illness means schizophrenia, schizoaffective disorder, major depressive disorder, bipolar disorder, paranoia and other psychotic disorders, obsessive-compulsive disorder, and panic disorder, as these terms are defined in the most recent edition of the diagnostic and statistical manual of mental disorders published by the American Psychiatric Association.
Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.
Acutely mentally ill means a condition which is limited to
Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).