The new standard is effective immediately and affects all drugs and biologics currently in development .
新标准即刻起效,对当前开发的所有药物和生物制剂均有效。
Manufacturing of biologics - increasing demand for monoclonal antibodies and recombinant proteins drives increases in capacities and innovative production technologies .
生物制品的制造:单株抗体与基因转换蛋白质的需求增加促进生产技术与能力的提升。
Similarly , follow-on biologics companies must expedite development of biosimilars of existing blockbuster drugs prior to patent expiration or risk losing market share to generic-drug competitors .
Taken together , the regulatory environment for biologics in the us , as elsewhere , has experienced a sea change over the previous decade .
总的来说,美国生物制剂的法规环境,也和其他地方一样,在过去10年里经历了极大的变化。
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 .
See the " guideline for submitting documentation for the stability of human drugs 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”。
Attention-getting problems on the transportation and storage management of veterinary biologics to the animal disease control organizations in prefecture or city .
州市动物疫控机构兽用生物制品储运管理应注意的问题。
Trends and challenges in biologics outsourcing .
生物制药技术外包的趋势和挑战。
Genericsthat are chemical equivalents to conventional drugs save americans atleast $ 10 billion per year . The food and drug administration , however , lacks the legal ability to approve generic versions of biologics .
The biologics control act is passed to ensure purity and safety of serums , vaccines , and similar products used to prevent or treat diseases in humans .