The CTX scheme requires a full submission including preclinical, pharmacology , safety, manufacturing and clinical data. The trial must be approved by both the TGA and IECs. Human clinical testing of a new drug requires the submission of an Investigational New Drug application that must include the results of preclinical studies, together with manufacturing information and anlalytical data. Clinical trials These are human studies in which there are three phases that can take around seven years to complete. I preliminary pharmacological evaluation.
Trials measure the safety and tolerability of a new drug in human volunteers.
The study is designed to investigate a dose range, to identify a safe dose. Phase II basic controlled evaluation. Trials are designed to determine the safety and efficacy of a potential drug in small groups of volunteers with the same type of disease. Dosage is further investigated, as is method, frequency and duration of administration, aiming to strike a balance between optimum administration and patient comfort to ensure the future market potential of the drug. Phase III extended clinical evaluation.