Influence of Simulated Gastrointestinal Fluids on Polymorphic Behavior of Anhydrous Carbamazepine Form III and Biopharmaceutical Relevance [0.03%]
模拟胃肠液对卡马西平无水Form III多晶型行为及生物药剂学的相关性影响研究
S B Bhise,M Rajkumar
S B Bhise
The dissolution behavior and bioavailability of carbamazepine (CBZ) is rate-limited by formation of carbamazepine dihydrate (CBZ-D) in dissolution fluids. The present investigation involves formation and biopharmaceutical evaluation of CBZ-...
Bijaya Ghosh,Rashmi Baser,Uma A Patil et al.
Bijaya Ghosh et al.
The present investigation is aimed at assessing the iontophoretic permeability of nicorandil to evaluate its feasibility for the development of an actively delivered transdermal system. Excised porcine skin was used for permeation study, an...
Root Cause Analysis of Tungsten-Induced Protein Aggregation in Pre-filled Syringes [0.03%]
预填充注射器中钨诱导蛋白质聚集的原因分析
Wei Liu,Rob Swift,Gianni Torraca et al.
Wei Liu et al.
Particles isolated from a pre-filled syringe containing a protein-based solution were identified as aggregated protein and tungsten. The origin of the tungsten was traced to the tungsten pins used in the supplier's syringe barrel forming pr...
Stephen E Langille,Cliff Campbell
Stephen E Langille
This article summarizes a recently completed research assignment conducted on behalf of the Food and Drug Administration's (FDA) Office of Pharmaceutical Science. The assignment addressed the issue of changing sterile drug manufacturing sit...
James C Greenwood
James C Greenwood
ASTM and ASME-BPE Standards--Complying with the Needs of the Pharmaceutical Industry [0.03%]
ASTM和ASME-BPE标准——满足制药行业的需求
William M Huitt
William M Huitt
Designing and building a pharmaceutical facility requires the owner, engineer of record, and constructor to be knowledgeable with regard to the industry codes and standards that apply to this effort. Up until 1997 there were no industry sta...
In Vitro Screening Methods To Assess the Potential of In Vivo Precipitation of Injectable Formulations upon Intravenous Administration [0.03%]
用于评估静脉注射给药后注射剂在体内心脏和肺部沉淀潜能的体外筛选方法
Agam R Sheth
Agam R Sheth
In vivo precipitation of injectable formulations upon intravenous administration is a major concern in formulation development. In this work, two in vitro screening tools, static dilution and dynamic injection, are developed to assess the p...
Evaluation of the microbial growth potential of pharmaceutical drug products and quality by design [0.03%]
药品质量和基于质量设计的微生物生长潜力评估
Anastasia G Lolas,John W Metcalfe
Anastasia G Lolas
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 ...
Jason J Z Liao,Yu Tian,Robert C Capen
Jason J Z Liao
Due to the comparative nature of a bioassay, the relative potency is usually used to describe the potency of a sample. Only when the two samples are similar can a valid and meaningful estimate of relative potency be obtained. Thus, assessin...
Identification of micro-organisms after milliflex rapid detection--a possibility to identify nonsterile findings in the milliflex rapid sterility test [0.03%]
Milliflex快速微生物检测后的微生物鉴定——一种鉴别Milliflex快速无菌检测试验中非无菌的方法的可能性研究
Jennifer C Gray,Dieter Morandell,Günther Gapp et al.
Jennifer C Gray et al.
The Milliflex Rapid System is used as a rapid microbiological method based on adenosine triphosphate (ATP) bioluminescence in the pharmaceutical industry to quantify the amount of micro-organisms present in water and in bioburden samples. T...