Analysing your Results

Do not attemt to analyse data from a scoping study as you would a screening study. You cannot test the effects of the parameters, since all the factors are varying simultaneously from their mild-to-centre-to-forcing settings. That means the factors are completely correlated or aliased; leading to just one effect)! Instead click on Graph Columns under the Design node on the left-hand tree structure

Select a factor from the X axis list, or if you created a descriptive factor (e.g., Condition in this example) you should use this. Note, the factor you choose represents all factors changing from mild to forcing

Cycle through all the responses in the Y axis list. You can Colour By each response to emphasize changes in result from mild-to-mid-to-forcing

Check the range & pattern of response values against the response goal or target. Also assess the background variation – differences between the repeat centre point results – is not exceesive and will provide good signal:noise ratio in subsequent studies (e.g., screening). If the results fail to meet your needs, they should suggest a direction for further improvement or additional work.

Analysis Tip: do not expect a scoping experiment to provide you with the same amount of information as a screening or optimisation study. They are not designed to identify which factor(s) are having an effect, or provide a detailed understanding the effects of the parameters in order to establish ideal settings or robust ranges for the parameters

Interpreting your Results

Simply interpret the graph columns plots. In this example, you will not achieve the goal for tablet Hardness of >11kp & the target for Dissolution Time of 240 mins ± 20mins using the mild settings. However, the centre point and forcing results suggest that these goals are achievable and are likely to lie inside this space. Use this knowledge to input into the next study (e.g., screening). If you needed to increase Hardness still further, you would need to stretch the forcing conditions beyond their current settings. You can always add experiments in a direction suggested by the scoping study results for verification.

Curvature in the dissolution response over the scoping range suggests you are currently operating over an optimum for this response. The centre point results for both responses are comparable providing some evidence of reproducibility.