Application of WAVE Bioreactor to Production of Biologics WAVE生物反应器在生物制品生产中的应用
The House bill differs from a similar Senate bill in that it does not provide a path for FDA approval of follow-on biologics. 但是在参议院的另一个类似法案中,FDA并没有得到审批“后继生物药”的权限。
See the "Guideline for Submitting Documentation for the Stability of Human Drug and Biologics" for assistance in fulfilling this requirement. 具体要求,参见“关于提交人类用药品和生物制品稳定性文件的指南”。
The Manual also contains the protocols for the production and the control of biologics for veterinary use. 手册还包含有兽医用生物制品生产和控制协议。
Requirement and Suggestion on Re-registration of Imported Veterinary Biologics 进口兽用生物制品再注册申报的要求及建议
These medicines, called biologics or biologicals, are typically injected and treat a range of conditions including anemia, rheumatoid arthritis, hepatitis and cancer. 这些药品,即所谓的生物制剂或生物制品,一般通过注射来治疗一系列的疾病,包括贫血、类风湿关节炎、肝炎和癌症。
Veterinary biologics needed for compulsory vaccination shall be produced by enterprises designated by the administrative department for veterinary medicine of the State Council. 强制免疫所需兽用生物制品,由国务院兽医行政管理部门指定的企业生产。
Green biologics has been working in China for three years. greenbiologics已在中国运营3年。
Biologics will witness a big boom in the autoimmune and inflammatory diseases arena and in other disease areas that have a significant unmet need. 在自身免疫性和感染性疾病领域,以及那些明显未被满足的疾病治疗领域,生物制品将有极大的发展空间。
Green biologics, which was founded in 2004, has developed microbial fermentation technology that enables waste and agricultural by-products to be turned into high-value chemicals and fuels. greenbiologics成立于2004年,已研发出微生物发酵技术,让废弃物和农业副产品得以转化为高价值的化工产品和燃料。
Breaking News Alerts Generic versions of certain biologics have been allowed in Europe for the last four years, but approval came only after manufacturers conducted rigorous human clinical trials. 最新消息提醒说某些生物药品在过去的四年里被允许,但只有制药企业实施了严格的人类临床试验才能得到批准。
Table I.Analytical technologies for assessment of biologics. 表一分析技术,生物制剂评估。
Since the earliest days of parenteral manufacturing it has been recognized that many drugs and biologics would not withstand a physical sterilization process in their final container. B, Interval between top sheet and foundation drapes covered by sterile pillowcases. 自打注射用药品生产开始,人们就认识到在最终容器内很多药物和生物制品无法承受物理灭菌过程。B上单与底单间隙用无菌枕套覆盖。
Biologics for rheumatoid arthritis work, but which is best? 类风湿性关节炎的生物制剂,哪个是最佳的?
The company said half of its new drugs entering trials this year will be biologics and it plans to bring a new biotech product to market every year starting in2011. 今年,礼来公司进入临床试验的药物一半是生物技术药物。公司计划自2011年起,每年有一个生物技术药物上市。
The world's pharmaceutical giants are aflutter over "biologics"– protein compounds used to make drugs that are difficult to copy into generic versions. 基于蛋白复合物制备而得的生物技术制剂具有难于仿制的特点,因此世界制药巨头们开始对生物制剂展示极大兴趣。
Since the1930s, Thimerosal has been widely used as a preservative in a number of biologics and drug products. 自1930年以来,在许多生物制品和药品中使用硫柳汞作为防腐剂。
Industrial experiment of acidic wastewater containing Hg treated by biologics in zinc smelter 含汞污酸生物制剂处理的工业试验研究
Biologics have a somewhat better success rate than small molecule drugs, but they remain far from a sure bet. 生物技术药物研发的成功率稍高于小分子药物,但它们距离稳赚不赔的目标仍相距甚远。
Field evaluation of biologics serves a necessary and useful purpose. 生物制品的现场评价是必需而有用的。
Verification of Method for Microbial Limit Test on Raw and Subsidiary Materials of Biologics 生物制品用原辅料微生物限度检测方法的验证
Methods Master and working seed lots were established according to the WHO Requirements for Biologics. Biological characteristics of the virus and stability of the vaccine were studied. 方法按WHO规程要求建立主种子批和工作种子批,检测病毒的生物学特性和疫苗稳定性。
The results are very satisfactory after applied the AFM to the field of nanometer material science and nanometer biologics. 使用电子开关对高低通滤波器进行智能控制;研究了AFM在纳米材料科学、纳米生物学中的应用,并且获得了非常满意的结果。
Transportation, Storage and Usage of Veterinary Biologics 兽用生物制品的运输、贮存与使用
Clinical experience and outlook for biologics in the management of asthma and allergy 哮喘和变态反应管理的临床经验和生物制剂的展望
Effect of active biologics of Chitosan on Rice Growth 脱乙酰壳聚糖活性生物制剂对水稻生长的影响
Conclusion The cells for production of biologics in China are contaminated with adventitious agents at a certain degree. 结论目前我国生物制品生产用细胞存在一定程度的外源因子污染。
Conclusions The results indicate that application of Stainer medium and TFF system can obtain purified diphtheria toxoid which meets the Requirements for Biologics of China. 结论应用Stainer培养基与TFF系统可获得符合我国现行规程要求的精制白喉类毒素。
The close attention has been played to the safety problems of genetically modified veterinary biologics as the same as to those of other biotechnological products. 像其它生物技术产品一样,兽用基因工程生物制品的安全性问题也引起了人们的广泛关注和重视。
Measures of Biosafety Control to Genetically Modified Veterinary Biologics in Research and Development 兽用基因工程生物制品研究与开发的生物安全控制措施