作者: 朵朵7 时间: 2014-6-12 02:05 PM
呜呜英文不好，帮不了呢作者: feitian 时间: 2014-6-14 07:19 PM
第一篇只能找到摘要PDA J Pharm Sci Technol. 2011 Jan-Feb;65(1):63-70.
Evaluation of the microbial growth potential of pharmaceutical drug products and quality by design.
Lolas AG1, Metcalfe JW.
Author information
Abstract
The microbial growth potential of a pharmaceutical drug product refers to the ability of microorganisms to survive and proliferate in the product. Each drug formulation possesses a different potential for supporting or inhibiting microbial growth. Understanding this microbial growth potential can have a significant effect on the development and design of the drug manufacturing process. This article describes how this attribute can exert this effect on manufacturing process development and design through real examples and case studies obtained from the regulatory review of new drug and biologics license applications. In addition, this article describes how understanding the microbial growth potential of a pharmaceutical drug product is an element of the Quality by Design paradigm and how this understanding can simplify the drug development process and lead to better process design.
LAY ABSTRACT:
The microbial growth potential of a pharmaceutical drug product refers to the ability of microorganisms to survive and proliferate in the product formulation. Each drug product formulation possesses a different potential for supporting or inhibiting microbial growth depending on its components. Understanding this microbial growth potential can have a significant effect on the development and design of the drug manufacturing process. This article describes how this attribute can affect manufacturing process development and design through real examples and case studies obtained from the regulatory review of new drug and biologics license applications. In addition, this article describes how understanding the microbial growth potential of a pharmaceutical drug product is an element of the Quality by Design paradigm and how this understanding can simplify the drug development process and lead to better process design.
第二篇见附件作者: feitian 时间: 2014-6-14 07:21 PM
第二篇文献全文