Defining the supratherapeutic dose is dependent on the investigational compound. Because of this, it is essential that you:
•    Know as much as possible about the compound. It is ideal if the maximum tolerated dose (MTD) has been defined. If an MTD has not been identified, a compilation of the adverse events observed during past studies, together with the dose at which the events occurred can be useful in evaluating a potential supratherapeutic dose. Pharmacokinetic data from past studies can be used to simulate exposure of the compound, if the compound was administered with a drug which inhibits the metabolism of the compound or if the patient takes more than the prescribed amount.
•    If the proposed supratherapeutic dose has not been previously administered to healthy participants, consider conducting a small pilot study in eight to 12 subjects to determine tolerability and the exposure levels achieved. The pilot study will document the tolerability of the proposed supratherapeutic dose prior to administration in the TQT study where 36 to 60 subjects would be exposed to the supratherapeutic dose.
•    Decide the route of administration for the compound. Whether it will be delivered orally, topically or by injection may play a role in determining the supratherapeutic dose. In the case of a topical product, if an oral dosage form is available, consideration should be given to conducting the TQT study with the oral dosage form which will achieve much higher exposure than the compound would when administered topically.