In- Process Validation Studies What Should Be The Blend Sample Size?

1.	In- Process Validation Studies What Should Be The Blend Sample Size?
Answer» 1x – 3x dosage UNIT range on case to case basis. As per USFDA guidance, SAMPLING size can be INCREASED from 1x –10 XS with ADEQUATE scientific justification. 1x – 3x dosage unit range on case to case basis. As per USFDA guidance, sampling size can be increased from 1x –10 xs with adequate scientific justification.

Answer»

1x – 3x dosage UNIT range on case to case basis. As per USFDA guidance, SAMPLING size can be INCREASED from 1x –10 XS with ADEQUATE scientific justification.

1x – 3x dosage unit range on case to case basis. As per USFDA guidance, sampling size can be increased from 1x –10 xs with adequate scientific justification.

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In- Process Validation Studies What Should Be The Blend Sample Size?

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