Activity

  • I think that there are some cases where shortening the time frame of a study is a good option. Using the bone void filler syringes from the last simulation as an example, we needed to verify a two year shelf life for the product without having two years to spend on the study. Yes, running a stability study for two years would give us accurate data, but by changing the storage conditions we could simulate long term aging within a shorter time frame and as long as there was no significant changes to the product in the accelerated conditions then it would be okay. So in cases where a study is acceptable or has been previously proven to be acceptable under accelerated conditions I think it is perfectly okay to do so.