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Related Concept Videos

Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Bioequivalence: Overview01:16

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Equivalence: In Vitro and In Vivo Bioequivalence01:17

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Bioequivalence studies are crucial in evaluating whether new drugs can match an approved one regarding pharmacological effects and clinical performance. These studies test if drugs, despite different dosage forms, share identical plasma concentration-time profiles. Three types of equivalence are central to these studies: chemical, pharmaceutical, and therapeutic. Chemical equivalence indicates that two or more drug products contain identical active ingredients in equal amounts. Pharmaceutical...
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Water functions as a solvent accommodating various solutes, which can be categorized under electrolytes and non-electrolytes. Non-electrolytes are usually held together by covalent bonds, restricting them from dissociating in solution, thereby leading to a lack of electrically charged components upon dissolving in water. They are predominantly organic molecules, such as glucose, creatinine, and urea. Electrolytes, on the other hand, are compounds that can break down into ions in water.
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
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Related Experiment Video

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Biobanking of Human Aqueous and Vitreous Liquid Biopsies for Molecular Analyses
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A 'compelling case' for bioliquids'.

Andrew Monaghan

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    |August 19, 2015
    PubMed
    Summary

    Second-generation bioliquids offer a practical renewable energy solution, often overlooked for carbon emission reduction. They should be prioritized for heating and power generation due to their efficiency and versatility.

    Area of Science:

    • Renewable Energy Technologies
    • Biomass Conversion
    • Sustainable Fuels

    Background:

    • Organizations often overlook bioliquids when seeking alternatives to fossil fuels for carbon emission reduction.
    • Bioliquids face challenges, including a "bad press" from environmental groups and a lack of "glamour" compared to newer renewable technologies.
    • Despite challenges, bioliquids are presented as a rational and informed choice for renewable energy.

    Purpose of the Study:

    • To advocate for the prioritization of second-generation bioliquids in renewable energy strategies.
    • To highlight the benefits of bioliquids as a primary or supplementary energy source.
    • To address misconceptions and promote the informed consideration of bioliquids.

    Main Methods:

    • Expert opinion and commercial director's perspective from a specialist bioliquid producer (UK Renewable Fuels).

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  • Argumentative outline based on "rational and informed reasoning."
  • Focus on the advantages of "second generation bioliquids."

    • Main Results:

    • Bioliquids are a viable and often overlooked renewable energy option.
    • Second-generation bioliquids are positioned as a "renewable of choice" for various applications.
    • Bioliquids can serve as both a primary and supplementary energy source.

    Conclusions:

    • Bioliquids, particularly second-generation types, deserve a prominent place in strategies for reducing carbon emissions.
    • The perceived drawbacks of bioliquids should be weighed against their practical benefits for energy generation.
    • Informed decision-making supports the adoption of bioliquids as a key renewable energy solution.