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RegisterType-II Variation: Waive in-vivo study by providing in-vitro data? [Study Assessment]
Hello everybody
And as I happen to have the ICH M-9 just in front of me for other reasons, I cite chapter 3 first paragraph:
"A drug product is eligible for a BCS-based biowaiver ... drug product is the same dosage form and strength"
Best regards!
❝ However all of the conditions required for a Class III waiver have to be met and this goes beyond simply showing dissolution similarity.
And as I happen to have the ICH M-9 just in front of me for other reasons, I cite chapter 3 first paragraph:
"A drug product is eligible for a BCS-based biowaiver ... drug product is the same dosage form and strength"
Best regards!
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Ing. Helmut Schütz