Bracketing and Matrixing Designs in

[@machindrasarak7665]

Nicely explained sir .will you please elaborate how to determine shelf life determination ? Minimum study requirements for submission the product in regulatory market?

[@hitendrakumarshah3718]

Sure, I will prepare session on this.

[@suryashree5941]

Here only you discussed accelerated or intermediate. these conditions only for 6 months, 0,6,9, (exatrapolated 12) But u r recommended examples are long term upto 36 or retest period Sir please explain why u mentioned long term and how to consider long term

[@hitendrakumarshah3718]

This training based on ICH guidelines for bracketing and matrixing. You can follow link below for further learning Stability Study in Pharmaceutical Industry kzbin.info/www/bejne/aHi8XmBoecmXj80

[@jankeemistri9054]

In case of bracketing, with respect to explained example of 75mg can b skipped as an intermediate level. But, 100 ml packing is done in different ampoules/vials, i.e. other than 15 ml and 500 ml How it can be justified?

[@hitendrakumarshah3718]

You need to select the extremes by comparing the various characteristics of the container closure system that may affect product stability. Your question is related to packing - in different packing profiles - In such case, you will not be able to select extremes. Hope, you got the point. For further details, you can go through the recording webinar again and elaborate your querry in more detail.