Abstract: The present invention relates to a method and system for planning a stability study of a pharmaceutical composition. According to the current invention a new statistical principle for designing studies is provided. It addresses directly that the aim of the stability study is to derive more precise and efficient specification limits. The method involves making estimates of the needs that might be encountered and in that way determine whether a given stability study model can provide the precision necessary to derive appropriate shelf-life specifications. The approach is based on utilizing normal distribution calculations of the obtainable specifications in Allen's formula. The terms that are estimated include the degradation rates such that in the estimated model, the specifications arrived at have at least a 90% chance of being better than projected by other methods. In addition the standard evaluation of the uncertainty of the slope is performed.

Abstract: A method for clinical surveillance of a treatment group and an other group involves defining an adverse event, possible a serious adverse event, noting each occurrence of the adverse events, and, starting at zero, calculating a cumulative sum of the adverse events by updating the cumulative sum each time a further adverse event is reported and, when the adverse event is in the treatment group, adding 1 to the cumulative sum, and, when the adverse event is in the other group, adding 0 to the cumulative sum. This invention also involves subtracting a chosen quantity K from the cumulative sum, comparing the cumulative sum to a predetermined alarm limit, determining when the cumulative sum reaches at least the predetermined alarm limit, and indicating the predetermined alarm limit has been reached.

Abstract: The present invention relates to a method and system for planning a stability study of a pharmaceutical composition. According to the current invention a new statistical principle for designing studies is provided. It addresses directly that the aim of the stability study is to derive more precise and efficient specification limits. The method involves making estimates of the needs that might be encountered and in that way determine whether a given stability study model can provide the precision necessary to derive appropriate shelf-life specifications. The approach is based on utilizing normal distribution calculations of the obtainable specifications in Allen's formula. The terms that are estimated include the degradation rates such that in the estimated model, the specifications arrived at have at least a 90% chance of being better than projected by other methods. In addition the standard evaluation of the uncertainty of the slope is performed.

Abstract: A method for clinical surveillance of a treatment group and an other group involves defining an adverse event, possible a serious adverse event, noting each occurrence of the adverse events, and, starting at zero, calculating a cumulative sum of the adverse events by updating the cumulative sum each time a further adverse event is reported and, when the adverse event is in the treatment group, adding 1 to the cumulative sum, and, when the adverse event is in the other group, adding 0 to the cumulative sum. This invention also involves subtracting a chosen quantity K from the cumulative sum, comparing the cumulative sum to a predetermined alarm limit, determining when the cumulative sum reaches at least the predetermined alarm limit, and indicating the predetermined alarm limit has been reached.