相关实验视频
Updated: Feb 13, 2026

10:42
Oral Biofilm Sampling for Microbiome Analysis in Healthy Children
Published on: December 31, 2017
17.9K
一个第一阶段,随机的,开放的标签研究,以评估Trofinetide作为即用口服溶液和健康成年人口服溶液的粉末的生物等价性
Mona Darwish1, Amy Yamamoto2, Yvonne Adegbenle2
1Acadia Pharmaceuticals Inc., 502 Carnegie Center, Suite 300, Princeton, NJ, 08540, USA. mdarwish@ACADIA-Pharm.com.
Advances in therapy
|February 12, 2026
概括
一种新的Trofinetide (TPOS) 粉末配方与口服溶液 (TOS) 生物相当,用于治疗雷特综合征. 这种TPOS配方具有优势,可以在不影响生物可用性的情况下用不同水量制备.
科学领域:
- 药理动力学和生物可用性研究
- 药物配方和开发 药物配方和开发
- 雷特综合征治疗方法 治疗方法
背景情况:
- 托菲尼提德已被批准用于治疗2岁以上的患者的雷特综合征,目前可作为即用口服溶液 (TOS) 提供.
- 一种新的用于口服溶液 (TPOS) 的托菲尼提德粉末具有潜在的优势,包括更小的包装,排除某些辅助剂,不需要冷藏.
研究的目的:
- 与现有的即用口服液 (TOS) 相比,评估一种新的用于口服液 (TPOS) 的托菲尼提德粉末与现有的即用口服液 (TOS) 的生物等价性.
- 评估TPOS的不同组成量对托菲尼提德生物可用性的影响.
主要方法:
- 一个随机的,开放的,三期的交叉研究,涉及38名健康成年人.
- 参与者接受了一次12000毫克口服剂量的TOS (60毫升),TPOS在60毫升水中,TPOS在25毫升水中.
- 通过比较Cmax,AUC0-t和AUC0-∞来确定生物等价性,几何平均比率的90%置信区间需要在80-125%范围内.
主要成果:
- 在TPOS (60毫升) 和TOS.之间,所有药理学参数 (AUC0-t,AUC0-∞,Cmax) 符合生物等效标准.
- 所有其他治疗比较,包括25毫升水中构成的TPOS,也符合生物等价性标准.
- 最常见的不良事件是腹 (15.8%);没有报告严重或意想不到的不良事件.
结论:
- 该研究表明TPOS和TOS之间的生物等价性,支持它们的临床可互换性.
- 可以在可调节的水量中构成TPOS,而不会影响trofinetide的生物利用性.
- 对于trofinetide的任何一种配方,都没有观察到任何意外的不良事件.
相关概念视频
Assessing Body Temperature - Oral
1.7K
Here are the steps to accurately measure oral temperature using an electronic thermometer:
Step 1:
Start by practicing proper hand hygiene to prevent the spread of microorganisms.
Step 2:
Take the thermometer out of the charging unit, switch it on, and wait for the ready sign.
Step 3:
Gently slide the probe cover until a click is heard. This simple action prevents cross-contamination and ensures the correct placement of the probe cover.
Step 4:
Instruct the patient to open their mouth and place...
Step 1:
Start by practicing proper hand hygiene to prevent the spread of microorganisms.
Step 2:
Take the thermometer out of the charging unit, switch it on, and wait for the ready sign.
Step 3:
Gently slide the probe cover until a click is heard. This simple action prevents cross-contamination and ensures the correct placement of the probe cover.
Step 4:
Instruct the patient to open their mouth and place...
1.7K
Bioequivalence Experimental Study Designs: Completely Randomized and Randomized Block Designs
256
Body:Bioequivalence experimental study designs are crucial methodologies used in evaluating and comparing the bioavailability of different drug products. These designs are categorized into various types: completely randomized, randomized block, repeated measures, cross and carry-over, and Latin square designs.Completely randomized designs involve randomly allocating treatments to all subjects participating in the experiment. This allocation is achieved by assigning unique random numbers to...
256
General Properties of Solutions
36.1K
Many common substances around us exist as a solution, such as ocean water, air, and gasoline. All solutions are mixtures of substances that are composed of varying amounts of two or more types of atoms or molecules. A mixture with a non-uniform composition is a heterogeneous mixture, whereas a mixture with a uniform composition is a homogeneous mixture. The components that make the homogeneous mixture are evenly spread out and thoroughly mixed.
36.1K
Oral Cavity
3.2K
The oral cavity, or the mouth, is a complex structure in humans that plays a vital role in our day-to-day lives. Its role is not only in chewing and swallowing food; it also plays a role in speech and facial expressions.
Teeth: The teeth are the hardest structures in our bodies. Humans have two sets of teeth throughout their lifetime: deciduous (baby) teeth and permanent teeth. Each tooth consists of several parts: the crown (visible part), the root (embedded in the jaw), enamel (hard outer...
Teeth: The teeth are the hardest structures in our bodies. Humans have two sets of teeth throughout their lifetime: deciduous (baby) teeth and permanent teeth. Each tooth consists of several parts: the crown (visible part), the root (embedded in the jaw), enamel (hard outer...
3.2K
Ideal Solutions
22.7K
According to Raoult’s law, the partial vapor pressure of a solvent in a solution is equal or identical to the vapor pressure of the pure solvent multiplied by its mole fraction in the solution. However, Raoult's Law is only valid for ideal solutions. For a solution to be ideal, the solvent-solute interaction must be just as strong as a solvent-solvent or solute-solute interaction. This suggests that both the solute and the solvent would use the same amount of energy to escape to the...
22.7K
Solution Formation
38.1K
There is no one solvent that can dissolve every type of solute. Some substances that readily dissolve in a certain solvent might be insoluble in a different solvent. A simple way to predict which substances dissolve in which solvent is the phrase "like dissolves like". This means that polar substances, such as salt and sugar, dissolve in a polar substance like water. In contrast, non-polar substances are more soluble in non-polar solvents such as carbon tetrachloride.
This selective...
This selective...
38.1K

