Personal Perspectives of NDA Products Development through 505(b)(2) Regulatory Pathway and A Few Cas

来源 :第二届全国生物颗粒学术研讨会、第三届国际工业药学和临床药学研讨会暨第一届岭南国际药学大会 | 被引量 : 0次 | 上传用户:zyr2007
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  1.Overview of FDA Approved NDA Products Using Modified Release Technologies in the Last Ten Years 2.FDA [505(b)(2)] Regulatory Pathway and Comparison of Differences among [505(b)(1)], [505(b)(2)] and [505(j)]3.Case Studies for [505(o)(2)] Using Modified Release Technologies 4.Summary of MR Platform Technologies used in [505(b)(2)] Products
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