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Related Concept Videos

Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

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Body: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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Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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Pharmaceutical Equivalents01:26

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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Body: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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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Related Experiment Video

Updated: Oct 20, 2025

Establishment of Rat Models Mimicking Gender-affirming Hormone Therapies
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Compounded bioidentical hormone products, a path forward.

Robert B MacArthur, Donald Mattison, Ruth M Parker

    Journal of the American Pharmacists Association : Japha
    |September 13, 2021
    PubMed
    Summary
    This summary is machine-generated.

    Millions use compounded bioidentical hormone therapies (cBHT), but their clinical utility remains unproven. Further research and regulatory action are needed to ensure safer use of these widely utilized products.

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    Area of Science:

    • Pharmacology
    • Endocrinology
    • Regulatory Science

    Background:

    • Compounded bioidentical hormone therapies (cBHT) are widely used by millions of individuals.
    • The use of cBHT products is reportedly increasing annually.
    • Current data on the safety, efficacy, and clinical utility of cBHT remains insufficient.

    Purpose of the Study:

    • To document the extensive utilization of cBHT.
    • To define clinical utility and highlight the lack of evidence supporting cBHT.
    • To propose actionable recommendations for pharmacists and regulators to enhance cBHT safety.

    Main Methods:

    • Review of current literature and market trends for cBHT.
    • Analysis of factors contributing to consumer demand for cBHT.
    • Examination of formulation challenges and comparative costs.

    Main Results:

    • Widespread and increasing use of cBHT products nationwide.
    • Identified lack of robust evidence for the clinical utility of cBHT.
    • Examples of consumer motivations, costs, and formulation complexities are presented.

    Conclusions:

    • Despite advancements like the Drug Supply Chain Security Act, continued efforts are necessary to improve cBHT safety and transparency.
    • Pharmacists and regulators must collaborate to promote safer practices and initiate studies on cBHT.
    • Further investigation is crucial to establish the evidence base for cBHT.