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注射用重组人甲状旁腺素(1-34)治疗绝经后妇女骨质疏松症患者的有效性和安全性的Ⅲ期临床试验
[Translation] Phase III clinical trial of the efficacy and safety of recombinant human parathyroid hormone (1-34) for injection in the treatment of osteoporosis in postmenopausal women
本研究是以阿仑膦酸钠作为阳性对照药,评价注射用重组人甲状旁腺素(1-34)治疗绝经后妇女骨质疏松症的有效性和安全性,为试验药物的注册上市提供支持。
[Translation] This study used alendronate sodium as a positive control drug to evaluate the efficacy and safety of recombinant human parathyroid hormone (1-34) for injection in the treatment of osteoporosis in postmenopausal women, and to provide support for the registration and marketing of the trial drug.
重组人甲状旁腺素治疗绝经后妇女骨质疏松症患者的安全性和有效性的II期临床试验
[Translation] Phase II clinical trial of the safety and efficacy of recombinant human parathyroid hormone in the treatment of osteoporosis in postmenopausal women
以鲑鱼降钙素鼻喷剂和特立帕肽注射液作为阳性对照,探索和评价重组人甲状旁腺素(1-34)治疗绝经后妇女骨质疏松症的剂量-效应关系和安全性,为Ⅲ期临床试验确定试验药物安全有效剂量提供依据。
[Translation] Using salmon calcitonin nasal spray and teriparatide injection as positive controls, the dose-effect relationship and safety of recombinant human parathyroid hormone (1-34) in the treatment of osteoporosis in postmenopausal women were explored and evaluated, providing a basis for determining the safe and effective dose of the test drug in Phase III clinical trials.
100 Clinical Results associated with Shanghai CAS Shenglongda Biotech (Group) Co. Ltd.
0 Patents (Medical) associated with Shanghai CAS Shenglongda Biotech (Group) Co. Ltd.
100 Deals associated with Shanghai CAS Shenglongda Biotech (Group) Co. Ltd.
100 Translational Medicine associated with Shanghai CAS Shenglongda Biotech (Group) Co. Ltd.