首页> 外文OA文献 >Response of authors to Ganju and Dias’ comments on ‘Inclusion of Placebos and Blinding for Ascending Dose First-in-Human Studies and Other Underpowered Phase 1 Studies Has Not Been Justified and on Balance is Not Useful’ by D. A. Parasrampuria and L. Z. B

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Response of authors to Ganju and Dias’ comments on ‘Inclusion of Placebos and Blinding for Ascending Dose First-in-Human Studies and Other Underpowered Phase 1 Studies Has Not Been Justified and on Balance is Not Useful’ by D. A. Parasrampuria and L. Z. B

机译：作者对甘茹和DIA的回应对“将安慰剂纳入并对上升剂量第一 - 人类研究和其他可行的阶段1研究”并未有合理，D. A.副血管和L.Z.B

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Dolly A. Parasrampuria; Leslie Z. Benet;
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1. Response of authors to Ganju and Dias' comments on 'Inclusion of Placebos and Blinding for Ascending Dose First-in-Human Studies and Other Underpowered Phase 1 Studies Has Not Been Justified and on Balance is Not Useful' by D. A. Parasrampuria and L. Z. Benet [J] . Basic & clinical pharmacology & toxicology. . 2015,第6期

机译：作者对Ganju和Dias的评论“ D. A. Parasrampuria和L. Z. Benet的论点“没有理由证明安慰剂和盲人用于递增剂量的首次人体研究和其他动力不足的第一阶段研究，并且总的来说没有用”。
2. Response to 'Inclusion of Placebos and Blinding for Ascending Dose First-in-Human Studies and Other Underpowered Phase 1 studies has not been Justified and on Balance is Not Useful' by DA Parasrampuria and LZ Benet [J] . Basic & clinical pharmacology & toxicology. . 2015,第6期

机译：DA Parasrampuria和LZ Benet对“增加剂量安慰剂和盲人剂量的首次人体研究和其他动力不足的1期研究尚无道理，总的来说没有用”的回应
3. Inclusion of Placebos and Blinding for Ascending Dose First-in-Human Studies and Other Underpowered Phase 1 Studies has not been Justified and on Balance is Not Useful [J] . Parasrampuria Dolly A., Benet Leslie Z. Basic & clinical pharmacology & toxicology. . 2015,第1期

机译：尚无理由将安慰剂和盲法用于剂量增加的首次人体研究和其他动力不足的第1阶段研究，总的来说没有用
4. Phase I Double Blind, Placebo Controlled, Ascending Single Intravenous Dose Study with a Synthetic Direct Thrombin Inhibitor, TGN255 [C] . S. Combe, G. Allen, T. Kennedy International Congress on Thrombosis . 2004

机译：I阶段双盲，安慰剂控制，用合成直接凝血酶抑制剂升序单静脉注射剂量研究，TGN255
5. A Phase 1B, Double-blind, Placebo-controlled, Parallel-group, Multi-dose Study of the Pharmacodynamics of NGM282 on Colonic Transit, Bile Acid Homeostasis and Fecal Fat in Subjects with Functional Constipation [D] . Oduyebo, Ibironke. 2018

机译：1B，双盲，安慰剂控制，并行组，NGM282对结肠转运，胆汁酸痛和患者功能性便秘的粪便脂肪的药物动力学的多剂量研究
6. A first-in-human randomized double-blind placebo-controlled single and multiple ascending oral dose study to assess the safety tolerability and pharmacokinetics of BZF961 with and without ritonavir in healthy adult volunteers [O] . Stephen Youngberg, Erin Brandt, Avantika Barve, 2018

机译：一项首次在人类中进行的随机双盲安慰剂对照单次和多次递增口服剂量研究以评估含或不含利托那韦的BZF961在健康成人志愿者中的安全性耐受性和药代动力学
7. A first-in-human randomized, double-blind, placebo-controlled, single- and multiple-ascending oral dose study of novel spiroindolone KAE609, to assess the safety, tolerability and pharmacokinetics in healthy adult volunteers [O] . 2014

机译：新型螺螺吲哚酮KAE609的首次人类随机，双盲，安慰剂对照，单次和多次递增口服剂量研究，以评估健康成人志愿者的安全性，耐受性和药代动力学

Response of authors to Ganju and Dias’ comments on ‘Inclusion of Placebos and Blinding for Ascending Dose First-in-Human Studies and Other Underpowered Phase 1 Studies Has Not Been Justified and on Balance is Not Useful’ by D. A. Parasrampuria and L. Z. B

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