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Author

P. Langguth

2 papers indexed here

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Sep 2026

Investigating the Impact of Food Induced Fluid Viscosity on Disintegration and Dissolution of Immediate Release Midodrine HCl Tablet

The prediction of bioavailability (BA) and bioequivalence (BE) for immediate-release (IR) solid oral dosage forms is critical during development and post-approval phases of drug products. ICH M13A provides the option of using in vitro tests, such as disintegration and dissolution in biorelevant media, pilot studies, an...

F. Doole, Ranganath Wahalathantrige Don, Ishwor Poudel et al. · 0 citations
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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