Speakers : Tom Tao, JMP China Pharmaceutical Industry Data Analysis Consultant
the speech topic : The use of statistical method selection in comparative studies
speech abstract :
In the scenarios of CMC process transfer, method transfer, and establishment of reduced models, it is necessary to compare the production data of different batches to prove that the process before and after the transfer is consistent, or to prove that the reduced model is consistent with the large scale. We can choose different methods to prove statistically, such as TOST equivalence test, Mean±3sd, tolerance interval, principal component analysis, etc. This speech will introduce different scenarios corresponding to these different methods to explain reasonably Consistency between batches.
