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Related Concept Videos

Phase Diagrams02:39

Phase Diagrams

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A phase diagram combines plots of pressure versus temperature for the liquid-gas, solid-liquid, and solid-gas phase-transition equilibria of a substance. These diagrams indicate the physical states that exist under specific conditions of pressure and temperature and also provide the pressure dependence of the phase-transition temperatures (melting points, sublimation points, boiling points). Regions or areas labeled solid, liquid, and gas represent single phases, while lines or curves represent...
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Phase Transitions02:31

Phase Transitions

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Whether solid, liquid, or gas, a substance's state depends on the order and arrangement of its particles (atoms, molecules, or ions). Particles in the solid pack closely together, generally in a pattern. The particles vibrate about their fixed positions but do not move or squeeze past their neighbors. In liquids, although the particles are closely spaced, they are randomly arranged. The position of the particles are not fixed—that is, they are free to move past their neighbors to...
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Inductance: Single-Phase And Three-Phase Line01:28

Inductance: Single-Phase And Three-Phase Line

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Understanding the inductance of transmission lines is crucial for efficient design and operation in electrical power systems. This discussion delves into the inductance characteristics of single-phase two-wire and three-phase three-wire transmission lines with equal phase spacing.
Single-Phase Two-Wire Line:
A single-phase line consists of two solid cylindrical conductors, denoted as x and y. Each conductor carries phasor currents ix and iy, respectively. Given that the sum of these currents is...
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Capacitance: Single-Phase And Three-Phase Line01:25

Capacitance: Single-Phase And Three-Phase Line

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In electrical power systems, understanding the capacitance of transmission lines is fundamental for efficient operation.
Single-Phase Lines
Consider a single-phase, two-wire transmission line with equal phase spacing energized by a voltage source. One conductor carries a uniform positive charge, while the other carries an equal negative charge. The capacitance C of the line can be derived from the voltage V between the conductors. For a one-meter section of the line, the capacitance is given...
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Phase Changes01:19

Phase Changes

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Phase transitions play an important theoretical and practical role in the study of heat flow. In melting or fusion, a solid turns into a liquid; the opposite process is freezing. In evaporation, a liquid turns into a gas; the opposite process is condensation.
A substance melts or freezes at a temperature called its melting point and boils or condenses at its boiling point. These temperatures depend on pressure. High pressure favors the denser form of the substance, so typically, high pressure...
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Phase-lead and Phase-lag Controllers01:22

Phase-lead and Phase-lag Controllers

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Understanding the working function of different types of controllers can be illustrated with practical analogies, such as adjusting a stereo's volume equalizer. Cranking up the bass involves a phase-lead controller, which functions as a high-pass filter, while increasing the treble uses a phase-lag controller, which acts as a low-pass filter. PD controllers, similar to high-pass filters, enhance the system's response to high-frequency components. PI controllers, akin to low-pass...
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Related Experiment Video

Updated: Jan 22, 2026

Protocol for the Solid-phase Synthesis of Oligomers of RNA Containing a 2'-O-thiophenylmethyl Modification and Characterization via Circular Dichroism
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Protocol for the Solid-phase Synthesis of Oligomers of RNA Containing a 2'-O-thiophenylmethyl Modification and Characterization via Circular Dichroism

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Adding dose modifications into Phase II and Phase II/III seamless trials.

John Spivack1, Bin Cheng2, Bruce Levin2

  • 1Department of Environmental Medicine and Public Health, Mount Sinai Medical Center, New York, NY, USA.

Statistical Methods in Medical Research
|July 4, 2019
PubMed
Summary

This study introduces a flexible method for dose modification in seamless Phase II and Phase II/III clinical trials, allowing dose selection at interim analyses while maintaining error rate control. The technique enhances trial efficiency and adaptability, potentially saving trials and improving outcomes.

Keywords:
Adaptive designdose additiondose modificationfamilywise error ratenonmonotonic dose response

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Area of Science:

  • Clinical trial design
  • Biostatistics
  • Pharmaceutical research

Background:

  • Seamless Phase II and Phase II/III trials require efficient dose selection strategies.
  • Traditional methods may lack flexibility in adapting to interim data.
  • Maintaining statistical rigor, particularly familywise error rate control, is crucial.

Purpose of the Study:

  • To present a novel technique for incorporating dose modifications into seamless Phase II and Phase II/III trials.
  • To enable flexible dose selection at interim analyses.
  • To ensure strong control of the familywise error rate.

Main Methods:

  • A flexible method for dose modification adaptable to interim analyses.
  • Application in both Phase II and seamless Phase II/III trial designs.
  • Demonstration with examples including adaptive exploration for nonmonotonic dose-response curves.

Main Results:

  • The proposed method is convenient and can be prespecified or adaptive.
  • Strong control of the familywise error rate is maintained.
  • Examples show potential to "save" Phase II trials and improve efficiency in Phase II/III trials over standard rules.

Conclusions:

  • The presented technique offers a practical and statistically sound approach to dose modification in adaptive clinical trials.
  • It enhances efficiency and flexibility, particularly for complex dose-response relationships.
  • This method supports robust decision-making at interim analyses.