Biorelevant dissolution methods, formulation

Our formulation development activities we developed both a biorelevant dissolution method, and a drug product release method. At this point in development, all of our formulation development activities are complete, making the biorelevant method less important. The formulation(s) is fixed, and we are now concerned with demonstrating that we can consistently manufacture batches of drug product. We will also want to show that the release characteristics of the dosage unit do not change on stability. Oiu" drug product release method will fulfill this role and will be the primary dissolution method, until the method conditions need to be revisited when in vivo data become available from om first clinical studies. At that time, the method should be revisited to evaluate how biorelevant our in vitro data are. 

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