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Author

Takuto Niino

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Aug 2026

Biowaiver monograph for immediate-release solid oral dosage forms: Dabigatran etexilate.

The feasibility of applying a biowaiver based on Biopharmaceutics Classification System (BCS) to immediate-release oral capsules containing dabigatran etexilate was evaluated according to the ICH M9 guideline. Based on literature data and experimental results, the Dose/Solubility ratio of the drug substance does not me...

Takuto Niino, Masaki Iida, Tamaki Fujii et al. · 0 citations

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