Utilizing 505(b)(2) Regulatory Pathway for New Drug Applications: An Overview on the Advanced Formulation Approach and Challenges

This article was originally published by Jiayi Chen, Zhifeng Zhao, Xinyu Wang and Jingjun Huang in Drug Repurposing – Advances, Scopes and Opportunities in Drug Discovery and is republished here under a  Creative Commons Attribution 3.0 License Abstract More than 50% of approved drugs on the market contain poorly water-soluble APIs, which typically are associated […] Source