Generic pharmaceutical products marketing approval

Dissolution tests are used nowadays in the pharmaceutical industry in a wide variety of applications to help identify which formulations will produce the best results in the clinic, to release products to the market, to verify batch-to-batch reproducibility, and to help identify whether changes made to formulations or their manufacturing procedure after marketing approval are likely to affect the performance in the clinic. Further, dissolution tests can sometimes be implemented to help determine whether a generic version of the medicine can be approved or not. 

Active substances such as pharmaceuticals and agrochemicals can only be economically marketed while they are under patent protection, before suppliers of generic products enter the market. Therefore, producers of such products cannot simply concentrate on costly research. As soon as possible after clinical trials and marketing approval, worldwide sales of the product must begin so that the remaining patent time can be used for... 

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