Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities
This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based...
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Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Format: | Book |
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Frontiers Media S.A.,
2021-10-01T00:00:00Z.
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A1234.567 |
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