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The IPRP BEWGG is pleased to share an updated assessment report template for Biopharmaceutics Classification System (BCS) biowaivers in accordance with the ICH M9 guideline. Furthermore, a first set of assessment report templates for dosage form biowaivers (oral and injectable dosage forms) were released. Interested parties may visit the following pages to download the templates and to obtain more information.
https://www.iprp.global/page/biopharmaceutics-classification-system-bcs-biowaivers
https://www.iprp.global/page/biowaivers-various-dosage-forms