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Regulatory Pathways for Translating Controlled Release and Biological Combination Products

机译:翻译控释和生物结合产品的监管途径

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摘要

Nhile orally administered controlled release products are the backbone of the pharmaceutical industry,development and mainstreaming of implantable or njectable controlled release systems has been slow to fllow.Both the complexity of the products themselves and the previously uncharted regulatory pathway led to delayed new product introduction.
机译:尽管口服给药的控释产品是制药行业的骨干力量,但可植入或可注射控释系统的发展和主流化进展缓慢。产品本身的复杂性和以前未知的监管途径都导致新产品的推出延迟。

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