Risk analysis of sterile production plants: a new and simple, workable approach [0.03%]
无菌药品生产厂房的风险管理：一种新的、简单的实用办法
Guenther Gapp,Peter Holzknecht
Guenther Gapp
A sterile active ingredient plant and a sterile finished dosage filling plant both comprise very complex production processes and systems. The sterility of the final product cannot be assured solely by sterility testing, in-process controls...
Quality and integrity of data in research, development, and innovation: a risk analysis method applied to laboratory notebooks in a university pilot plant [0.03%]
研究、开发和创新中的数据质量与完整性：一种用于大学中试工厂实验室记录本的风险分析方法
Anna Fàbregas-Fernández,Encarna García-Montoya,Pilar Pérez-Lozano et al.
Anna Fàbregas-Fernández et al.
Risk analysis tools can be applied in the early stages of the research, development, and innovation of pharmaceutical drugs. We used a risk ranking and filtering method to optimize time resources in internal audits of project development do...
Development of sustained release floating drug delivery system for norfloxacin: in vitro and in vivo evaluation [0.03%]
诺氟沙星缓释漂浮给药系统的设计及体内外评价
Mohan Guguloth,Ramesh Bomma,Kishan Veerabrahma
Mohan Guguloth
Norfloxacin is a drug with an absorption window. Its oral bioavailability is 30-40% and is a case for improvement by appropriate formulation design. In our previous study, gastroretentive floating tablets for norfloxacin were developed empl...
Wish you were here! [0.03%]
愿你在此风景中漫步！
Maik Jornitz,Govind Rao
Maik Jornitz
A review of the current scientific and regulatory status of nanomedicines and the challenges ahead [0.03%]
纳米药物的当前科学和监管状况及未来的挑战综述
Sia Chong Hock,Yan Mei Ying,Chan Lai Wah
Sia Chong Hock
Nanomedicines refer to drugs, medical devices, and health products developed using nanotechnology with the aim of diagnosing, monitoring, and treating diseases at the molecular level. Due to their nano size, nanomedicines offer advantages o...
A general assessment of the physiochemical factors that influence leachables accumulation in pharmaceutical drug products and related solutions [0.03%]
药剂产品和相关溶液中浸出物积累的影响因素的综合评估
Dennis Jenke
Dennis Jenke
The accumulation of organic compounds associated with plastic materials into pharmaceutical products and their associated solutions has important suitability for use consequences for those pharmaceutical solutions, most notably in terms of ...
Design-for-Six-Sigma To Develop a Bioprocess Knowledge Management Framework [0.03%]
运用六西格玛法开发生物工艺知识管理框架
Beth Junker,Gargi Maheshwari,Todd Ranheim et al.
Beth Junker et al.
Owing to the high costs associated with biopharmaceutical development, considerable pressure has developed for the biopharmaceutical industry to increase productivity by becoming more lean and flexible. The ability to reuse knowledge was id...
Effect of Size on the Biodistribution and Blood Clearance of Etoposide-Loaded PLGA Nanoparticles [0.03%]
粒径对载依托泊苷PLGA纳米粒生物分布及血液清除特性影响的研究
Khushwant S Yadav,Krishna Chuttani,Anil K Mishra et al.
Khushwant S Yadav et al.
Approaches used to avoid uptake of the injected particles by the reticuloendothelial system include modification of the particle properties such as surface charge and particle size. In the present study the effect of mean particle size of e...
Intravenous administration of recombinant human IL-10 suppresses the development of anti-thy 1-induced glomerulosclerosis in rats [0.03%]
静脉注射rhIL-10抑制抗Thy 1诱导的大鼠系膜增生性肾小球肾炎发展为硬化性肾小球肾炎
H Rachmawati,L Beljaars,C Reker-Smit et al.
H Rachmawati et al.
Aim: Interleukin-10 (IL-10) is a cytokine with potent antifibrotic and anti-inflammatory properties. However, IL-10 has a very short plasma half-life in vivo. This prompted the question whether a short intravenous treatme...
Impact of Formulation and Processing Parameters on Silicone Extraction from Cyclic Olefin Copolymer (COC) Syringes [0.03%]
配方和加工参数对环烯烃共聚物(COC)注射器中硅胶析出的影响
Dipesh Shah,Jim Cronin,Molly Chacko et al.
Dipesh Shah et al.
The effect of various formulation and process parameters on the extraction of silicone from siliconized cyclic olefin copolymer (COC) syringes is reported. The impact of proprietary silicone curing process on COC syringe barrels was evaluat...