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Updated: Jun 6, 2025

Synthesis of Stimuli-responsive Nanogels using Aqueous One-step Crosslinking and Co-nanopolymerization
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米国における生物学的薬と小分子薬の法的保護の違い

Olivier J Wouters1, Matthew Vogel2, William B Feldman3,4

  • 1Department of Health Policy, London School of Economics and Political Science, London, United Kingdom.

JAMA
|November 25, 2024
PubMed
まとめ

生物学的薬剤と小分子薬剤は 開発期間とコストが似ていますが 生物学的薬剤は 市場での独占性が長くなります これは米国の法律が小分子薬よりも 生物学的開発に過剰な報酬を与える可能性があることを示唆しています

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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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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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