90折
Handbook of Pharmaceutical Manufacturing Formulations ─ Sterile Products
商品資訊
系列名：Handbook of Pharmaceutical Manufacturing
ISBN13：9781420081305
出版社：Informa Healthcare
作者：Sarfaraz Niazi
出版日：2009/09/21
裝訂／頁數：精裝／434頁
規格：27.9cm*22.2cm*3.8cm (高/寬/厚)
版次：2
定價
：NT$ 13000 元優惠價
：
90 折 11700 元
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商品簡介
商品簡介
No other area of regulatory compliance receives more attention and scrutiny by regulatory authorities than the regulation of sterile products, for obvious reasons. With the increasing number of potent products, particularly the new line of small protein products, joining the long list of proven sterile products, the technology of manufacturing sterile products has evolved into a very sophisticated industry.
Highlights from Sterile Products, Volume Six include:
- formulations of sterile dosage forms, regulatory filing requirements of sterile preparations, and cGMP compliance, all of which are tied together in the final preparation of the CMC sections of regulatory applications
- specifications of a manufacturing facility to manufacture compliant sterile products
- NDA or aNDA filing requirements of sterile products
- an alphabetical presentation of formulations of pharmaceutical products based on their generic names
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