These are the articles on sterile pharmaceutical manufacturing, those are helpful to new as well as experienced pharmaceutical professionals. This page is updated regularly, therefore, don't forget to visit it again.
It was stressed at the meeting that efforts must be continued to promote the study of the Party's new theories, and educate and guide Party members and officials to gain a clear understanding of the way, direction, methods and intellect for performing their duties, foster inner strength, enhan...
Biosafety study shall mainly focus on immunogenicity safety: immunotoxicology evaluation and immunogen control and immunochemical testing. Guideline on Recombinant Collagen Wound Dressings The document confirms that the collagen wound dressings are Class II device. When classified into subcategories of -01 wo...
Only ICH guidelines for stability testing (Q1B) gives the guidance on photostability and states that the light source should be a combination of the UV and visible light. Following table defines different conditions followed for the forced degradation in pharmaceutical industries. A big question arises...
publication Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics to setting expiration dating periods for more complex ... WR Fairweather,TYD Lin,R Kelly - 《Journal of Pharmaceutical Sciences》 被引量: 20发表: 2010年 Gas chromatographic method for the determination ...
There is another recent study of fiber supplementation that also claims benefit, and this was through the uncontrolled use of an ovo-vegetarian diet with over 30 g of fiber for every 2000 kcal. Maintenance of remission to one year was a remarkable 92% [154]. See also recommendation 8. ...
proposingaretestperiodforadrugsubstanceorashelflifeforadrugproductthat extendsbeyondtheperiodcoveredby“availabledatafromthestabilitystudyunder thelong-termstoragecondition”(hereafterreferredtoaslong-termdata). 1.2Background Theguidanceontheevaluationandstatisticalanalysisofstabilitydataprovidedin theparentguidelineisbr...
Rayyan—a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210. https://doi.org/10.1186/s13643-016-0384-4. Article Google Scholar Holey EA, Feeley JL, Dixon J, Whittaker VJ. An exploration of the use of simple statistics to measure consensus and stability in Delphi ...
•Study on Electrochemical Corrosion Mechanism of Iron and Steel Materials •Study on the evolution law of surface passivation film stability and corrosion potential changes during corrosion of steel materials •Design and Development of Key Steel Materials for High Performance Fuel Cells ...
2. 2.1.3稳定性研究stability study 无论使用何种设计方法,都需要进行最终灭菌产品的稳定性研究。考察最终灭菌程序对产品性质稳定性影响的试验可包括产品的降解、含量、pH值、颜色、缓冲能力以及产品的其它质量特性。灭菌时,杀灭微生物的效果和活性成分的降解都随着时间和温度而累积。这意味着加热和冷却的变化将影响产品...