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Quality by Design: Next Steps to Realize Opportunities? - page 20 / 37

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ICH Q6A DECISION TREES #7: SETTING ACCEPTANCE CRITERIA FOR DRUG PRODUCT DISSOLUTION

What specific test conditions and acceptance criteria are appropriate? [IR]

dissolution significantly affect BA?

Develop test conditions and acceptance

 distinguish batches with unacceptable BA

YES

NO

YES

NO

YES

NO

Do changes in formulation or manufacturing variables affect dissolution?

Are these changes controlled by another procedure

and acceptance criterion?

Adopt appropriate test conditions and acceptance criteria without

regard to discriminating power, to

pass clinically acceptable batches.

Adopt test conditions and acceptance

criteria which can distinguish

these changes. Generally, single point

acceptance criteria  are acceptable.

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