Bracketing and Matrixing Designs in

#stability #ich #pharmaceutical #pharma #fda #shelflife #quality #qualitycontrol
#subscribetomychannel - / @hitendrakumarshah3718
This training session will take you through an understanding of the ICH Guide, stability study, and its reduction techniques.
The training will include below points;
Brief introduction of the concept, brief strategy
Know your Trainer
Disclaimer or clarification by the guideline
Applicability of reduced design
Bracketing - Design factors, strength and container closure size and/or fills
Example of Bracketing approach
Matrixing - Design factors, test reduction plans
Applicability and degree of reduction
Potential risk with Bracktign and Matrixing Approach
Q&A Vote of Thanks
If you have any question/s, please feel free to raise your questions in the comment section. I will reply to you.
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/ @hitendrakumarshah3718
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[@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.

[@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.