Rosiglitazone quantification in rat plasma using high performance liquid chromatography with mass spectrometric detection and its application to pre-clinical pharmacokinetic studies [0.03%]
高效液相色谱-质谱法测定大鼠血浆中罗格列酮并用于药代动力学研究
Karunanidhi Santhana Lakshmi,Tirumala Rajesh
Karunanidhi Santhana Lakshmi
A rapid and sensitive high performance liquid chromatography-mass spectrometry method has been developed for quantitative determination of Rosiglitazone, a thiazolidinedione drug used for the treatment of type II diabetes mellitus in rat pl...
The importance of accurate microorganism identification in microbial challenge tests of membrane filters--part I [0.03%]
膜滤器微生物挑战试验的准确鉴定微生物的重要性——第一部分
I Kaesler,G Haake,H Hennig et al.
I Kaesler et al.
Microbial challenge testing is a common procedure to determine the retention efficiency, performance, and validity of a sterilizing-grade filter. The ASTM 838-05 standard describes a bacteria challenge test procedure based on Brevundimonas ...
Govind Rao
Govind Rao
Nutritional Effects on the Growth, Cell Size, and Resistance to Stress of Acholeplasma laidlawii [0.03%]
营养对Laidlawi螺旋体生长、细胞大小和抗逆性的影响
Martha Folmsbee,Courtney Noah,Morven McAlister
Martha Folmsbee
Due to their lack of a cell wall, mycoplasmas are useful models for the study of biological membranes. However, they are much less appreciated by cell culture laboratories due to their unfortunate tendency to contaminate cell culture lines ...
Prerequisites for Optimized Performance of the Eisai 1088W Automated Inspection System [0.03%]
艾斯aily 1088W自动化检查系统的性能优化前提条件研究
James A Melchore
James A Melchore
Numerous companies have ordered fully automated inspections systems as a means of improving inspection performance and reducing costs. A common complaint made is that automated technology generates excessive rejection. A time-proven combina...
Effect of the resolution of measurements in the behavior of the shewhart control charts for means [0.03%]
测量分辨率对均值图表行为的影响
Nora Meneces,Silvino A Olivera,Carlos D Saccone et al.
Nora Meneces et al.
Measurements of limited resolution change the behavior of a Shewhart average chart in two ways. The standard deviation of measurements differs from process standard deviation due to rounded values and discreteness of values of subgroup aver...
Richard M Formato,Raffaele Potami,Iftekhar Ahmed
Richard M Formato
Through a detailed case study the authors demonstrate, for the first time, the capability of using advanced modeling techniques to correctly simulate the transient temperature response of a convective flow-based thermal shipper design. The ...
Elevated Endotoxin Levels in Human Intravenous Immunoglobulin Concentrates Caused by (1->3)-{beta}-D-Glucans [0.03%]
人用静脉注射丙种球蛋白中的内毒素水平升高由（1->3）-β-D-葡聚糖引起
Andrea Buchacher,Dagmar Krause,Gerda Wiry et al.
Andrea Buchacher et al.
Endotoxins have been measured routinely in the final product and during the production process to produce non-pyrogenic parenterals. Limulus-amoebocyte-lysate-reactive material was found in in-process samples and final product of one of Oct...
Application of Quality by Design (QbD) Principles to Extractables/Leachables Assessment. Establishing a Design Space for Terminally Sterilized Aqueous Drug Products Stored in a Plastic Packaging System [0.03%]
基于质量的设计（QbD）原理在可提取物和浸出物评估中的应用。建立用于塑料包装系统的终端灭菌水性药物产品的设计空间
Dennis Jenke
Dennis Jenke
The concept of quality by design (QbD) reflects the current global regulatory thinking related to pharmaceutical products. A cornerstone of the QbD paradigm is the concept of a design space, where the design space is a multidimensional comb...
Importance of early characterization of physicochemical properties in developing high-dose intravenous infusion regimens for poorly water-soluble compounds [0.03%]
难溶性药物高剂量静脉输注给药制剂开发中早期开展理化性质研究的重要性分析
Akash Jain,Weijia Zheng,Sudhakar Garad et al.
Akash Jain et al.
TECHNICAL ABSTRACT: The aim of this work is to highlight the importance of the early characterization of physico-chemical properties to design an intravenous infusion regimen for a poorly water-soluble model compound. Compound X is a crysta...