目前各监管机构对基因治疗产品的生物分布研究可能有不同的要求,为基因治疗产品的开发带来了挑战。国际药物监管计划(IPRP)的基因治疗工作组(GTWG)于2018年6月编写了Expectations for Biodistribution Assessments for Gene Therapy Pro...目前各监管机构对基因治疗产品的生物分布研究可能有不同的要求,为基因治疗产品的开发带来了挑战。国际药物监管计划(IPRP)的基因治疗工作组(GTWG)于2018年6月编写了Expectations for Biodistribution Assessments for Gene Therapy Products意见书,该文件代表了当前不同地区的药品监管机构对支持基因治疗产品进入临床试验和上市申请时需要开展的非临床生物分布研究的认识,重点讨论了支持首次临床试验的生物分布研究、试验设计需考虑因素以及允许在首次临床试验后开展生物分布研究的情况。本文拟通过对该意见书的介绍,概述基因治疗药物生物分布研究的一般考虑,希望对我国基因治疗产品的生物分布研究相关的研发和审评工作提供参考。展开更多
The hypoxia signaling pathway is an evolutionarily conserved cellular signaling pathway present in animals ranging from Caenorhabditis elegans to mammals.The pathway is crucial for oxygen homeostasis maintenance.Hypox...The hypoxia signaling pathway is an evolutionarily conserved cellular signaling pathway present in animals ranging from Caenorhabditis elegans to mammals.The pathway is crucial for oxygen homeostasis maintenance.Hypoxia-inducible factors(HIF-1αand HIF-2α)are master regulators in the hypoxia signaling pathway.Oxygen concentrations vary a lot in the aquatic environment.To deal with this,fishes have adapted and developed varying strategies for living in hypoxic conditions.Investigations into the strategies and mechanisms of hypoxia adaptation in fishes will allow us to understand fish speciation and breed hypoxia-tolerant fish species/strains.This review summarizes the process of the hypoxia signaling pathway and its regulation,as well as the mechanism of hypoxia adaptation in fishes.展开更多
文摘目前各监管机构对基因治疗产品的生物分布研究可能有不同的要求,为基因治疗产品的开发带来了挑战。国际药物监管计划(IPRP)的基因治疗工作组(GTWG)于2018年6月编写了Expectations for Biodistribution Assessments for Gene Therapy Products意见书,该文件代表了当前不同地区的药品监管机构对支持基因治疗产品进入临床试验和上市申请时需要开展的非临床生物分布研究的认识,重点讨论了支持首次临床试验的生物分布研究、试验设计需考虑因素以及允许在首次临床试验后开展生物分布研究的情况。本文拟通过对该意见书的介绍,概述基因治疗药物生物分布研究的一般考虑,希望对我国基因治疗产品的生物分布研究相关的研发和审评工作提供参考。
文摘The hypoxia signaling pathway is an evolutionarily conserved cellular signaling pathway present in animals ranging from Caenorhabditis elegans to mammals.The pathway is crucial for oxygen homeostasis maintenance.Hypoxia-inducible factors(HIF-1αand HIF-2α)are master regulators in the hypoxia signaling pathway.Oxygen concentrations vary a lot in the aquatic environment.To deal with this,fishes have adapted and developed varying strategies for living in hypoxic conditions.Investigations into the strategies and mechanisms of hypoxia adaptation in fishes will allow us to understand fish speciation and breed hypoxia-tolerant fish species/strains.This review summarizes the process of the hypoxia signaling pathway and its regulation,as well as the mechanism of hypoxia adaptation in fishes.
