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【求助】再次求助在线的斑竹和高手帮我看看翻的对否？药代动力学及相关统计

nanfeiyan9999

2007/08/15

画线部分尤其拿不准．
BM-57　is　generally well tolerated and proven efficacious for the treatment of HIV-1 infection in patients who have failed their current antiretroviral therapies (ARTs) with documented resistance to at least one drug in each of the 3 class es of licensed oral antiretrovirals.
BM-57具有良好耐受性，可用来治疗被HIV-1感染的病人，这些病人经常用的抗逆转录病毒(ARTs)疗法治疗失败，至少对三类中任何一类口服抗逆转录病毒药物中的一种药物具有抗药性。The initial Phase I lactose formulation was developed as a probe, fit-for-purpose， formulation
to initiate clinical studies with the intent to continue with formulation development.
把Ⅰ期乳糖配方作为临床研究的适用性摸索配方来研究，以达到持续研究配方的目的。
Consequently, the Phase I poloxamer (20%) formulation was developed which possessed
improved pharmacokinetic and physical properties, including a lower peak to trough ratio
and the advantage of increasing drug loading from 25% (Phase I lactose) to 50%(Phase I
poloxamer), allowing a 400 mg potency tablet.
结果Ⅰ期泊洛沙姆配方具有改良的药物代谢动力学特性和物理性质，包括较低的峰谷比和载药量增加范围从25% (Ⅰ期乳糖配方)到 50%(Ⅰ期泊洛沙姆配方），效价片为400 mg还是耐受剂量为400mg.

However, manufacturing and scale-up
difficulties associated with the highly plastic nature and strain-rate sensitivity of this
formulation necessitated slight modifications leading to the development of the Phase
II/III /FMI formulation containing 12% poloxamer.
但此配方的高塑性和应变率敏感性导致生产和工业化放大的困难，需要略做调整，因此对含有12%泊洛沙姆的Ⅱ/Ⅲ/ FMI期配方进行研究。

This is supported further by pharmacokinetic/pharmacodynamic (PK/PD) analyses which suggest, at most, a modest association of drug concentration with viral response in this concentration range.
药动学/药效学的分析结果进一步证明了以上观点，其分析结果表明，在这个浓度范围内，药物浓度与病毒反应略有相关性。
this formulation was found to exhibit tablet hardness sensitivity to
compression speed.In order to improve processability with respect to tablet compression
and strain-rate sensitivity of the formulation, the amount of poloxamer 407 was reduced
from 20% to12% for the PhaseⅡ/Ⅲ/ FMI poloxamer formulations.
此配方的片剂硬度与压片速度具有相关性。为了提高此配方压片质量和拉伸变形应变速率敏感性，Ⅱ/Ⅲ/ FMI泊洛沙姆配方中泊洛沙姆407的含量从20% 减少到12%。

Relative Bioavaitability of an BM-57 Pediatric Probe Formulation
and Bilayer Formulation Study (Protocol020)
BM-57儿科摸索性配方和双层膜配方的相对生物利用度

For the bilayer formulation, the C24hr geometric mean (90% CI) was 42.1 nM (36.2, 48.9) where the lower bound of the confidence interval exceeded the target trough concentration of 33nM.
双层膜配方C24hr几何均值(90% 置信区间)是42.1 nM(36.2, 48.9), trough浓度值33nM在置信区间外.

As described in more detail in [Sec. 21], a population PK model was developed
from a pooled set of data from extensively sampled profile data from 5 Phase I and II
studies.
更多细节参见[Sec. 21], 通过对来自5个Ⅰ和Ⅱ期研究中大量样本的数据分析，研究其群体药动学模型。

Line - 50%百分数
Box - 25-75%百分数
Whiskers - 10-90%百分数（三个都是坐标图上的参数，一个盒子一样的图，不知道什么东西）

In the PK/PD analyses, no clinically meaningful association with C12 hr was obtained for any longer term response measure in the setting of a high proportion of favorable responses, suggesting that concentrations in this range were at the top of the dose-response curve
在PK/PD分析中，对高比例效应进行长期测量，C12 hr值无显著临床联系，表明此范围下浓度在剂量效应曲线顶点。

After single-dose administration of BM-57, AUC0-∞and C12 hr increase approximately dose proportionally over the dose range 10mg to 1200 mg. CMAX appears to increase slightly less than proportionally over this same dose range.After multiple-dose administration of BM-57, AUC0-12 and CMAX increase approximately dose proportionally,while C12 hr appears to incresae moderately less than dose proportionally.
单剂量给予BM-57其AUC0-∞和 C12 hr值,在10mg 到1200 mg剂量范围内,成比例增加. CMAX在此剂量范围内略低于成比例增加值. 多剂量给予BM-57, AUC0-12 和 CMAX值与给予剂量成比例增加,而C12 hr略低于成比例增加值.

After multiple-dose administration of BM-57,steady state appears to have been achieved within two days of dosing at all dose levels. The average accumulation rations(steady state versus single dose) for AUC0-12 and CMAX across the dose range studied ranged from approximately 0.7 to 1.2 and the average accumulation ratio for C12 hr ranged from approximately 1.2 to 1.6.
多剂量口服给予BM-57后,所有剂量在两天内达到稳态. 在整个剂量范围内,AUC0-12 和CMAX的平均累积率范围约为0.7到 1.2, C12 hr平均累积率范围约为1.2到 1.6

There is not enough evidence to conclude that at least one of either the calcium phosphate tablet or the PhaseⅡ lactose tablet has a mean C12hr value that is not lower than that of the Phase Ⅰ lactose tablet to a clinically meaningful degree.
从临床意义上讲, 无充分证据表明, 磷酸钙片剂或Ⅱ乳糖片剂C12hr均值等于或高于Ⅰ期乳糖片剂C12hr均值.

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相关话题

happyjyl

第1楼2007/08/15

BM-57具有良好的耐受性，对那些用现有抗逆转录病毒疗法治疗失败的HIV-1患者有效。这些患者对三类口服抗逆转录病毒药物中的每一类都至少有一种药有抗药性，因而用现有抗逆转录病毒疗法治疗失败。

这里的with是表示原因，所以我把它翻译出来了。意思明白，但翻译出来还是有些拗口。楼主可以再到丁香园去问问，那里做药动的人很多。

0

nanfeiyan9999

第2楼2007/08/15

去过了，人多嘴杂，很少遇到专业翻译．我药动学的东西今天就结稿了，我很喜欢这个论坛，尤其几位斑竹．以后会经常来的．我的专业也不是药代，所以这次有些困难．我也请教了一个教药代的老师，但是还剩这些死角．如果有时间还是请帮看两眼吧，哈哈难为了
happyjyl 发表:BM-57具有良好的耐受性，对那些用现有抗逆转录病毒疗法治疗失败的HIV-1患者有效。这些患者对三类口服抗逆转录病毒药物中的每一类都至少有一种药有抗药性，因而用现有抗逆转录病毒疗法治疗失败。

这里的with是表示原因，所以我把它翻译出来了。意思明白，但翻译出来还是有些拗口。楼主可以再到丁香园去问问，那里做药动的人很多。

0

happyjyl

第3楼2007/08/15

这里的documented是指有记录的，即该患者曾经用过这三类药物中的任何一类，至少对每一类中的一种药物有耐药性。
nanfeiyan9999 发表:BM-57　is　generally well tolerated and proven efficacious for the treatment of HIV-1 infection in patients who have failed their current antiretroviral therapies (ARTs) with documented resistance to at least one drug in each of the 3 classes of licensed oral antiretrovirals.

0

happyjyl

第4楼2007/08/15

我问了医学部的同事，他说这句话意译就可以了。意思是一期处方采用乳糖作探索性研究。
nanfeiyan9999 发表:The initial Phase I lactose formulation was developed as a probe, fit-for-purpose， formulation
to initiate clinical studies with the intent to continue with formulation development.

0

happyjyl

第5楼2007/08/15

这里的potency是指强度，可以不译。就是400mg片剂。
nanfeiyan9999 发表:allowing a 400 mg potency tablet.

0

nanfeiyan9999

第6楼2007/08/15

恩,这句意思和语法都已经明白了,多谢老大.
happyjyl 发表:这里的documented是指有记录的，即该患者曾经用过这三类药物中的任何一类，至少对每一类中的一种药物有耐药性。

0

happyjyl

第7楼2007/08/15

因而在Ⅱ/Ⅲ/ FMI期处方中加入12％泊洛沙姆进行研究。
nanfeiyan9999 发表:However, manufacturing and scale-up difficulties associated with the highly plastic nature and strain-rate sensitivity of this
formulation necessitated slight modifications leading to the development of the Phase II/III /FMI formulation containing 12% poloxamer.
因此对含有12%泊洛沙姆的Ⅱ/Ⅲ/ FMI期配方进行研究。

0

闲鹤野云

第8楼2007/08/15

楼主：Line - 50%百分数
Box - 25-75%百分数
Whiskers - 10-90%百分数（三个都是坐标图上的参数，一个盒子一样的图，不知道什么东西）

Ruojun:应该是标示不同的曲线吧。Line - 50%百分数线性的
Box - 25-75%百分数方框形
Whiskers 须状？？

0

闲鹤野云

第9楼2007/08/15

楼主：However, manufacturing and scale-up
difficulties associated with the highly plastic nature and strain-rate sensitivity of this
formulation necessitated slight modifications leading to the development of the Phase
II/III /FMI formulation containing 12% poloxamer.
但此配方的高塑性和应变率敏感性导致生产和工业化放大的困难，需要略做调整，因此对含有12%泊洛沙姆的Ⅱ/Ⅲ/ FMI期配方进行研究。

Ruojun:但此配方的高塑性和应变率敏感性导致生产和工业化放大的困难，需要略做调整，因而开发了含有12%泊洛沙姆的Ⅱ/Ⅲ/ FMI期配方。

0

闲鹤野云

第10楼2007/08/15

楼主：This is supported further by pharmacokinetic/pharmacodynamic (PK/PD) analyses which suggest, at most, a modest association of drug concentration with viral response in this concentration range.
药动学/药效学的分析结果进一步证明了以上观点，其分析结果表明，在这个浓度范围内，药物浓度与病毒反应略有相关性。

ruojun:药动学/药效学的分析结果进一步支持以上的观点/结论，这些分析结果表明，至少在这个浓度范围内，药物浓度与病毒反应略有相关性。

0

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