AANA journal
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Drug development involves the chemical identification and characterization of a compound to determine stability and define the drug's preliminary actions. Preclinical research follows in animals to develop a pharmacokinetic profile to determine dose range, biotransformation, elimination, and toxicology. The 4 phases of clinical research, phase 1 to phase 4, encompass a progressive investigation of healthy subjects, otherwise healthy patients, to patients with a target disease to obtain US Food and Drug Administration (FDA) approval. ⋯ The duration of action of Ro 48-6791 as measured by the OAA/S score and HTLW test did not differ between groups. Ro 48-6791 seemed to be a safe and effective agent to achieve conscious sedation in outpatients undergoing short invasive procedures. However, clinical drug development of Ro 48-6791 was stopped because it did not meet the efficacy criteria of an ultra-short-acting benzodiazepine.