当前“以患者为中心”的药物研发(patient focused drug development,PFDD)理念被制药行业和各国监管机构广泛接纳并应用到临床研发的各个阶段,且逐渐扩展到药学研发中。在此基础上,“以患者为中心的质量标准”(patient-centric specifi...当前“以患者为中心”的药物研发(patient focused drug development,PFDD)理念被制药行业和各国监管机构广泛接纳并应用到临床研发的各个阶段,且逐渐扩展到药学研发中。在此基础上,“以患者为中心的质量标准”(patient-centric specifications,PCS)应运而生。PCS是一种基于科学和风险的质量标准制定办法,侧重于质量属性对患者安全性和有效性影响的风险评估,确定与临床相关的可接受范围,从而为患者提供符合预期的药品,尽可能提高患者的临床获益。PCS建立在大量的知识经验积累和全生命周期管理基础之上。本文将围绕对质量标准的理解,探讨PCS在治疗类生物制品中的应用。展开更多
生物药(bio-therapeutics)是指采用生物技术制备的、临床上用于疾病治疗的大分子生物制品,具有结构复杂、异质性高等特点,科学严谨的生物药通用名命名,是区分生物药物质基础的主要依据,也是药品生命周期管理的重要基础。世界卫生组织(Wo...生物药(bio-therapeutics)是指采用生物技术制备的、临床上用于疾病治疗的大分子生物制品,具有结构复杂、异质性高等特点,科学严谨的生物药通用名命名,是区分生物药物质基础的主要依据,也是药品生命周期管理的重要基础。世界卫生组织(World Health Organization,WHO)协调建立的国际非专利名称(International Nonproprietary Names,INN)是全球药物命名的标准化体系。从INN的起源,以及生物药INN的类别、发生与发展为主线,以较为详实的数据统计和分析,呈现了全球生物药的衍化进程,从不同的角度纵览生物药技术发展历程,对生物药的研发设计、技术标准及监管策略的考量均具有一定的参考意义。展开更多
The high price of synthetic fertilisers and the price barrier for biochar as a soil amendment have encouraged the exploration of using biochar in fertiliser replacement formulations. Biochars coupled with fertilisers ...The high price of synthetic fertilisers and the price barrier for biochar as a soil amendment have encouraged the exploration of using biochar in fertiliser replacement formulations. Biochars coupled with fertilisers can be applied at lower application rates to achieve benefits in plant growth and nutrition, as well as soil biological fertility. It is necessary to evaluate the use of biochar as a fertiliser substitute. Therefore, this study investigated the comparative influences of biochars, including Acacia saligna （AS）, Simcoa jarrah （S J） and Wundowie jarrah （W J）, mineral fertiliser with microbes （MF ＋ M）, biochar-mineral complex （BMC） and their combination on mycorrhizal colonisation, growth and nutrition of wheat in a glasshouse experiment and sorghum in field conditions. BMC ＋ MF ＋ M treatment produced higher mycorrhizal colonisation than MF ＋ M alone, indicating that BMC had a significant role in increasing mycorrhizal colonisation. SJ （treated with acetic acid） and MF ＋ M treatments, as well as AS ＋ MF ＋ M application, showed similar effects on mycorrhizal colonisation, but lower colonisation than the BMC ＋ MF ＋ M treatment. Ovcrall~ the BMC ＋ MF ＋ M treatment supported the maximum shoot, root and total plant dry weight followed by AS ＋ MF ＋ M and WJ ＋ MF ＋ M. The MF ＋ M treatment had the maximum shoot N and K concentrations, while BMC ＋ MF ＋ M application had the maximum shoot P concentration. AS ＋ MF -4- M and WJ ＋ MF ＋ M treatments supported the maximum N uptake by wheat shoots, while BMC ＋ MF ＋ M supported the maximum P uptake. The results showed that biochars and BMCs could increase mycorrhizal colonisation, plant growth and nutrient uptake of wheat, particularly N, P, K, S and Zn. The field experiment confirmed that BMC application at a rate of 300 kg ha-1 could increase the yield of irrigated sorghum on a loam soil and provide better applied P use efficiency compared to a water-soluble fertiliser alone. These results indicated that biochar-based fertilisers might increase the resilience and sustainability of dryland cropping in environments such as in Western Australia and warrant further field evaluation.展开更多
文摘当前“以患者为中心”的药物研发(patient focused drug development,PFDD)理念被制药行业和各国监管机构广泛接纳并应用到临床研发的各个阶段,且逐渐扩展到药学研发中。在此基础上,“以患者为中心的质量标准”(patient-centric specifications,PCS)应运而生。PCS是一种基于科学和风险的质量标准制定办法,侧重于质量属性对患者安全性和有效性影响的风险评估,确定与临床相关的可接受范围,从而为患者提供符合预期的药品,尽可能提高患者的临床获益。PCS建立在大量的知识经验积累和全生命周期管理基础之上。本文将围绕对质量标准的理解,探讨PCS在治疗类生物制品中的应用。
文摘生物药(bio-therapeutics)是指采用生物技术制备的、临床上用于疾病治疗的大分子生物制品,具有结构复杂、异质性高等特点,科学严谨的生物药通用名命名,是区分生物药物质基础的主要依据,也是药品生命周期管理的重要基础。世界卫生组织(World Health Organization,WHO)协调建立的国际非专利名称(International Nonproprietary Names,INN)是全球药物命名的标准化体系。从INN的起源,以及生物药INN的类别、发生与发展为主线,以较为详实的数据统计和分析,呈现了全球生物药的衍化进程,从不同的角度纵览生物药技术发展历程,对生物药的研发设计、技术标准及监管策略的考量均具有一定的参考意义。
基金Anthroterra Pty Ltd.,Australia and Australian Minerals Fertilisers Pty Ltd.for funding as well as the Royce family of Moonyoonooka near Geraldton,Australia for the use of their farm for the field experiment
文摘The high price of synthetic fertilisers and the price barrier for biochar as a soil amendment have encouraged the exploration of using biochar in fertiliser replacement formulations. Biochars coupled with fertilisers can be applied at lower application rates to achieve benefits in plant growth and nutrition, as well as soil biological fertility. It is necessary to evaluate the use of biochar as a fertiliser substitute. Therefore, this study investigated the comparative influences of biochars, including Acacia saligna （AS）, Simcoa jarrah （S J） and Wundowie jarrah （W J）, mineral fertiliser with microbes （MF ＋ M）, biochar-mineral complex （BMC） and their combination on mycorrhizal colonisation, growth and nutrition of wheat in a glasshouse experiment and sorghum in field conditions. BMC ＋ MF ＋ M treatment produced higher mycorrhizal colonisation than MF ＋ M alone, indicating that BMC had a significant role in increasing mycorrhizal colonisation. SJ （treated with acetic acid） and MF ＋ M treatments, as well as AS ＋ MF ＋ M application, showed similar effects on mycorrhizal colonisation, but lower colonisation than the BMC ＋ MF ＋ M treatment. Ovcrall~ the BMC ＋ MF ＋ M treatment supported the maximum shoot, root and total plant dry weight followed by AS ＋ MF ＋ M and WJ ＋ MF ＋ M. The MF ＋ M treatment had the maximum shoot N and K concentrations, while BMC ＋ MF ＋ M application had the maximum shoot P concentration. AS ＋ MF -4- M and WJ ＋ MF ＋ M treatments supported the maximum N uptake by wheat shoots, while BMC ＋ MF ＋ M supported the maximum P uptake. The results showed that biochars and BMCs could increase mycorrhizal colonisation, plant growth and nutrient uptake of wheat, particularly N, P, K, S and Zn. The field experiment confirmed that BMC application at a rate of 300 kg ha-1 could increase the yield of irrigated sorghum on a loam soil and provide better applied P use efficiency compared to a water-soluble fertiliser alone. These results indicated that biochar-based fertilisers might increase the resilience and sustainability of dryland cropping in environments such as in Western Australia and warrant further field evaluation.
