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Related Concept Videos

Standard Deviation01:10

Standard Deviation

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The most commonly used measure of variation is the standard deviation. It is a numerical value measuring how far data values are from their mean. The standard deviation value is small when the data are concentrated close to the mean, exhibiting slight variation or spread. The standard deviation value is never negative, it is either positive or zero. The standard deviation is larger when the data values are more spread out from the mean, which means the data values are exhibiting more variation.
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Nurses bear specific legal responsibilities under several federal statutes, including:
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Units and Standards of Measurement01:10

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A physical quantity is defined either by specifying its measurement method or by stating how it is calculated from other measurements. For example, consider a metallic cube. We might define its mass and dimensions by specifying methods for measuring them, such as using a weighing machine and a meter scale. Then, we could define the volume by stating that it is the cube of its side, and we could calculate the density as the mass divided by the volume.
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Testing a Claim about Standard Deviation01:19

Testing a Claim about Standard Deviation

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A complete procedure to test a claim about population standard deviation or population variance is explained here.
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Standard Solutions01:14

Standard Solutions

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Standard solutions refer to solutions with a precisely known concentration or composition. A primary standard is a highly pure, high molar mass, stable substance that is entirely soluble in water, the most commonly used solvent in analytical chemistry. The primary standard solution can be used to standardize secondary standards, which are substances with known concentrations but are less pure and stable. Standard solutions are essential for achieving accurate and reliable results in analytical...
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Ethical Standards I01:25

Ethical Standards I

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The American Nurses Association (ANA) created and implemented the first nationally accepted Code of Ethics for Nurses with Interpretive Statements. The Code of Ethics is a living document regularly updated by the ANA and establishes an ethical standard that is non-negotiable for nurses in all roles and settings.
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Do Standards Matter? What is Their Value?

Fouad Atouf1, Jaap Venema1

  • 1United States Pharmacopeial Convention, Rockville, Maryland 20852.

Journal of Pharmaceutical Sciences
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PubMed
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Public standards are crucial for managing expectations in global markets. This review examines their value in the pharmaceutical industry, particularly for biosimilars, ensuring quality and accessibility.

Keywords:
BiologicsEconomic valueInsulinMonoclonal antibodiesReference standardsRegulation

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Area of Science:

  • Pharmaceutical Science
  • Regulatory Science
  • Biotechnology

Background:

  • Standards are essential for global commerce, ensuring safety and efficacy across diverse products and services.
  • Their importance can be overlooked for new products, like biosimilars, despite successful implementation in other sectors.

Purpose of the Study:

  • To review the value and application of public standards in the pharmaceutical industry.
  • To explore standards for complex biologics and biosimilars, focusing on societal value and industry burden.
  • To assess the sustainability, transparency, and public trust in standard development.

Main Methods:

  • Literature review and analysis of public standards in pharmaceuticals.
  • Case studies on the creation and management of standards for biologics.
  • Assessment of standards' impact on biosimilar accessibility and development.

Main Results:

  • Public standards enhance quality and manage expectations for goods and services.
  • Standards for complex biologics can be developed to maximize societal benefit and minimize industry impact.
  • Transparency and sustainability are key to maintaining public trust in standard development.

Conclusions:

  • Standards are vital for ensuring access to high-quality, affordable biosimilars.
  • Effective standards facilitate efficient product development and regulatory review for next-generation pharmaceuticals.
  • Continued focus on standard development is necessary for the pharmaceutical industry's future.