Author

James E. Polli

3 papers indexed here

We haven’t gathered this author’s papers yet. Follow them and we’ll fetch their work.

Not the right person? Other researchers publish under this name.

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. · Journal of Pharmacy and Scie... · 0 citations

Review Open access Sep 2026

Importance of Single Global Regulatory Standards for the Assessment of Generic and Biosimilar Medicines to Advance Patient Access

Generic and biosimilar medicines are foundational to sustainable healthcare, enabling broader patient access globally through high-quality, cost-effective alternatives. However, their market access is hindered by regulatory fragmentation across major authorities, where regulatory expectations are not always clearly ali...

Antonela Rodriguez, Vishalakshi Krishnan, James E. Polli et al. · AAPS Journal · 0 citations

Open access Sep 2026

In vitro evaluation of water-insoluble silicates and polyvinylpyrrolidone-vinyl acetate as oral carriers for amorphous ritonavir: dissolution enhancement and the role of phosphatidylcholine.

Porous silicates have been investigated as drug carriers to promote the solubility and in vitro dissolution of poorly water-soluble drugs, owing to their potential to adsorb drug molecules in the amorphous form within their structural cavities. This study aimed to evaluate the efficiency of bentonite (BT), Aeroperl 300...

Gaurav Dhumal, Adélaïde Savoy, M. Kuentz et al. · International journal of pha... · 0 citations