In many cases the amount of product

In many cases the amount of product involved is not sufficient to allow for chemical or physical analysis of the material dispensed as part of simulation of use, and there would be too little product remaining in the container at the end of the study for this to be analysed. Allowance will need to be made for such situations in any guidance document. The use of alternative approaches will need to be allowed for where special limitations apply, although applicants should present a reasoned justification for the lack of need for such tests or for the design of the studies applied.