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356h When Fully Implemented Will  Form

356h When Fully Implemented Will Form

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hello everyone my name is Ashish Roscoe ghee and today I will talk about our assessment process while reviewing generic injectable drug device combination products but before I start with my part of the presentation here is a piece a brief message from office of pharmaceutical quality and I'll let you go through the next five slides on your own so you may ask what is the purpose or importance of our assessment process with respect to combination products well the assessment process is important to ensure that the general form is therapeutically equivalent to orally that is it has the same clinical effect and safety profile as are already under conditions specified in the product labeling and this will enable the generate form to be freely substituted for its early so with this thought in mind we came up with following objectives the objectives of today's presentation is to discuss various aspects of quality assessment of a generate combination drug device product and we hope that with

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