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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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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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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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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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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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Research and Education Needs for Complex Generics.

Sydney Stern1, Jill Coghlan2, Vishalakshi Krishnan2

  • 1Department of Pharmaceutical Sciences, University of Maryland, 20 Penn Street, Baltimore, Maryland, 21201, USA.

Pharmaceutical Research
|December 24, 2021
PubMed
Summary
This summary is machine-generated.

A survey identified key challenges in developing complex generics, focusing on product types, analytical methods for bioequivalence, and educational priorities. Results guide future research for the Center for Research on Complex Generics (CRCG).

Keywords:
bioequivalencecomplex genericformulationgenericsurvey

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Development
  • Regulatory Science

Background:

  • Complex generics present unique challenges in demonstrating bioequivalence and development.
  • These products are a key focus of the U.S. Food and Drug Administration's (FDA) Generic Drug User Fee Amendments (GDUFA) II.
  • The Center for Research on Complex Generics (CRCG) was established to address these development hurdles.

Purpose of the Study:

  • To survey scientific challenges in complex generic drug development.
  • To identify priorities for research and education by the CRCG.
  • To gather public input on complex product types, analytical methods, and educational needs.

Main Methods:

  • A public survey was conducted via the CRCG website.
  • Questions focused on complex product categories, bioequivalence analytical methods, and educational topics.
  • Survey responses were analyzed to determine top priorities.

Main Results:

  • Top complex product categories: complex injectables, formulations, nanomaterials; drug-device combination products; inhalation/nasal products.
  • Top analytical methods: physiologically-based pharmacokinetic modeling, oral absorption models, data analytics/machine learning.
  • Top educational topics: complex injectables/formulations/nanomaterials, drug-device combinations, data analytics/modeling.

Conclusions:

  • Survey results highlight critical areas for complex generic development.
  • These findings will direct the CRCG's initial research and educational initiatives.
  • Addressing these priorities is crucial for advancing complex generic accessibility.