关于中国在临床中使用计算机模拟的问题？之前有想法在美国注册IND，于是先报了PIND，也与CBER等开了一次电话会，其中提到了一个计算机模拟（Model-Base Drug Development）,主要是涉及定量药理学这个领域，于是国内问了一些CRO公司，大部分都说不知道或者就认为是临床前的模拟，境外的CRO公司倒是有咨询到有团队做这个的，但是对这个计算机模拟确实不够了解，也不知道这么大比钱花了到底有多大意义，现在想问下各位前辈国内是否有做这个的机构或者公司，亦或者对新药计算机模拟临床试验有了解给我一些建议，大谢！查看更多2个回答 . 18人已关注
银杏叶总黄酮自微乳化口腔速溶膜的制备及其性质研究？作者：肖璐 [1] 易涛 [2] 刘颖 [1] 宦娣 [1] 何吉奎 [1] Author：XIAO Lu [1] YI Tao [2] LIU Ying [1] HUAN Di [1] HE Ji-kui [1] 作者单位：西南大学药学院,重庆,400715 西南大学药学院,重庆,400715;澳门科技大学,澳门药物及健康应用研究所,中国,澳门 刊 名：中草药 ISTICPKU Journal：CHINESE TRADITIONAL AND HERBAL DRUGS 年，卷(期)：2011, 42(8) 分类号：R283.6查看更多2个回答 . 6人已关注
Science：注射强力抗体抑制血液中HIV病毒？12月23日，来自美国NIH的科学家们在国际学术期刊上发表了一项最新研究进展，他们报告称注射一种叫做VRC01的强效抗体就能够抑制未接受抗逆转录病毒治疗的HIV携带者血液中的HIV病毒水平。研究人员还发现通过静脉注射或皮下注射方式将VRC01抗体注入病毒携带者体内具有非常好的安全性和耐受性，并且注入的抗体能够在病人血液中保持较长时间。 Virologic effects of broadly neutralizing antibody VRC01 administration during chronic HIV-1 infection http://stm.sciencemag.org/content/7/319/319ra206 Passive aggression for HIV Antibodies that neutralize HIV could add to the therapeutic arsenal to prevent and treat disease. Lynch et al. have now tested one such antibody—VRC01—in HIV-infected individuals. Although little difference was observed in viral reservoir in individuals on antiretroviral therapy, plasma viremia was reduced in untreated subjects with a single infusion of VRC01, preferentially suppressing neutralization-sensitive strains. Passive immunization with neutralizing antibodies could therefore aid in viral suppression in HIV-infected individuals. Abstract Passive immunization with HIV-1–neutralizing monoclonal antibodies (mAbs) is being considered for prevention and treatment of HIV-1 infection. As therapeutic agents, mAbs could be used to suppress active virus replication, maintain suppression induced by antiretroviral therapy (ART), and/or decrease the size of the persistent virus reservoir. We assessed the impact of VRC01, a potent human mAb targeting the HIV-1 CD4 binding site, on ART-treated and untreated HIV-1–infected subjects. Among six ART-treated individuals with undetectable plasma viremia, two infusions of VRC01 did not reduce the peripheral blood cell–associated virus reservoir measured 4 weeks after the second infusion. In contrast, six of eight ART-untreated, viremic subjects infused with a single dose of VRC01 experienced a 1.1 to 1.8 log10 reduction in plasma viremia. The two subjects with minimal responses to VRC01 were found to have predominantly VRC01-resistant virus before treatment. Notably, two subjects with plasma virus load <1000 copies/ml demonstrated virus suppression to undetectable levels for over 20 days until VRC01 levels declined. Among the remaining four subjects with baseline virus loads between 3000 and 30,000 copies, viremia was only partially suppressed by mAb infusion, and we observed strong selection pressure for the outgrowth of less neutralization-sensitive viruses. In summary, a single infusion of mAb VRC01 significantly decreased plasma viremia and preferentially suppressed neutralization-sensitive virus strains. These data demonstrate the virological effect of this neutralizing antibody and highlight the need for combination strategies to maintain virus suppression.查看更多2个回答 . 1人已关注
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