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Effect of Food Composition on the PK of Isoniazid Quantitatively Explained Using Physiologically Based Biopharmaceutics Modeling.

Pub Date : 2024-04-24 DOI: 10.1208/s12248-024-00923-9 Xavier Pepin, Sandra Suarez-Sharp

Application of Advanced Modeling Approaches Supporting Generic Product Development Under GDUFA for Fiscal Year 2023.

Pub Date : 2024-04-24 DOI: 10.1208/s12248-024-00924-8 E. Tsakalozou, Yuqing Gong, A. Babiskin, Meng Hu, Youssef M. Mousa, Ross Walenga, Fang Wu, Miyoung Yoon, Sam G Raney, James E. Polli, A. Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao

Third Generation Solid Dispersion-Based Formulation of Novel Anti-Tubercular Agent Exhibited Improvement in Solubility, Dissolution and Biological Activity.

Pub Date : 2024-04-22 DOI: 10.1208/s12248-024-00922-w Gourav Paudwal, Rigzin Dolkar, Summaya Perveen, Rashmi Sharma, Parvinder Pal Singh, Prem N Gupta
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