Statistical Methods for comparing test and reference product equivalence for quality attributes

rayhope

Starting to get Involved
#1
Can anyone suggests Statistical Methods for comparing test and reference product equivalence for CMC quality attributes(Non clinical) Please suggest any guideline/ articles for reference.
 
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Enghabashy

Involved In Discussions
#3
The general ISO 2859-2:2020 Sampling procedures for inspection by attributes" it's general only "; but the FDA/PQRI guidance & relevant Conferences can Identify Critical Quality Attributes (CQA) ; Identify critical material attributes (CMA*) and critical process parameters (CPP), --etc.
 

rayhope

Starting to get Involved
#4
The general ISO 2859-2:2020 Sampling procedures for inspection by attributes" it's general only "; but the FDA/PQRI guidance & relevant Conferences can Identify Critical Quality Attributes (CQA) ; Identify critical material attributes (CMA*) and critical process parameters (CPP), --etc.
Thanks. Yes many articles available but any specific guidance which can be referred as standard practice like ISO or ASTM standards?
 
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