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Related Concept Videos

Bioequivalence: Overview01:16

Bioequivalence: Overview

1.5K
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 of Drugs: Drugs with Multiple Indications01:09

Bioequivalence of Drugs: Drugs with Multiple Indications

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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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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...
122
Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

119
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.
119
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

149
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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Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence

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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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Converging Generic Drug Product Development: Bioequivalence Design and Reference Product Selection.

Naseem Ahmad Charoo1

  • 1Neopharma LLC, Mussafah, PO Box 72900, Abu Dhabi, United Arab Emirates. naseem102@yahoo.com.

Clinical Pharmacokinetics
|August 7, 2020
PubMed
Summary
This summary is machine-generated.

Harmonizing reference product selection criteria for bioequivalence (BE) studies can reduce redundant drug testing. This harmonization offers significant cost savings and minimizes unnecessary drug exposure for healthy participants.

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Area of Science:

  • Pharmaceutical Sciences
  • Regulatory Affairs
  • Drug Development

Background:

  • Regulatory agencies worldwide have differing criteria for selecting reference products in bioequivalence (BE) studies.
  • These variations necessitate repetitive BE studies for the same generic product in different global markets, increasing costs and ethical concerns.

Purpose of the Study:

  • To analyze current regulatory policies on reference product selection for pharmaceutical equivalence (PE) and BE studies.
  • To discuss the cost implications of disparate regulatory practices.
  • To explore opportunities for harmonizing reference product selection criteria to reduce repetitive BE studies.

Main Methods:

  • Review of regulatory guidance documents from major global jurisdictions.
  • Comparative analysis of criteria for generic product definition, BE study design, and reference product selection.
  • Presentation of a case study illustrating potential harmonization and its economic benefits.

Main Results:

  • Significant differences exist in reference product selection criteria across major regulatory authorities.
  • Repetitive BE studies lead to substantial financial burdens and increased drug exposure for study participants.
  • Harmonization presents a viable strategy for streamlining BE study requirements.

Conclusions:

  • Harmonizing reference product selection criteria can lead to a single BE study accepted by multiple regulatory agencies.
  • This harmonization promises substantial reductions in operational costs for generic drug development.
  • Minimizing repetitive studies also decreases the exposure of healthy individuals to investigational drugs.