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Related Concept Videos

Bioequivalence of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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 indication due to...
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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that the same...
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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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Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Objective evaluation of generic-specific drug information.

Hisashi Iijima1, Toshimasa Koshimizu, Makoto Shiragami

  • 1Social and Administrative Pharmacy Science, College of Pharmacy, Nihon University, Funabashi City, Japan. h-iijima@c-yaku.or.jp

Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan
|March 3, 2007
PubMed
Summary

Information on generic drugs in Japan is limited compared to brand-name drugs, with significant variation between manufacturers. Proactive companies that update information post-release are preferable for consumers.

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Area of Science:

  • Pharmaceutical Sciences
  • Health Services Research
  • Drug Information Science

Background:

  • Generic drug use in Japan has stagnated, partly due to insufficient information availability.
  • Previous studies indicated that information on generic drugs is generally inferior to that of original brand-name drugs.

Purpose of the Study:

  • To evaluate the current availability and changes over time of generic-specific drug information.
  • To compare information quantity and content for individual generic drug products versus their original counterparts.

Main Methods:

  • Analysis of information provided for individual generic drug products across multiple pharmaceutical industries.
  • Comparison of information availability in August 2005 with previous data from May 2004 for specific ingredients.
  • Assessment of information content, focusing on areas like drug interactions, clinical efficacy, and side effects.

Main Results:

  • Information on generic drugs was found to be 31.1-57.3% of that for original drugs, with significant company-specific variations (16.6-69.4%).
  • Generic drugs provided less than 50% of the information on "drug interactions," "clinical efficacy," and "outline of side effects" compared to original drugs.
  • Information gaps were smaller when focusing solely on generic-specific data.

Conclusions:

  • Significant disparities exist in the amount and quality of information available for generic drugs.
  • Pharmaceutical companies that actively update post-release information are better choices when information is a key decision factor.
  • Addressing information availability is crucial for promoting generic drug utilization in Japan.