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Related Concept Videos

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

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...
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

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...
Antifungal Agents01:15

Antifungal Agents

Amphotericin B is a broad-spectrum antifungal agent that exploits structural differences between fungal and mammalian cell membranes. Its amphipathic structure—featuring a hydrophobic polyene-lactone ring and a hydrophilic region containing mycosamine and carboxylic acid groups—enables selective binding to ergosterol, a sterol predominantly found in fungal plasma membranes. This selective interaction underlies the drug’s antifungal activity, although weak binding to cholesterol contributes to...
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

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,...
Drug Dissolution: Requirements and Profile Comparison01:14

Drug Dissolution: Requirements and Profile Comparison

The acceptance criteria for dissolution profile data are anchored in Q values, representing the percentage of drug dissolved within a specified period. This assessment unfolds in three stages:First Stage: The test passes if all six drug dosage units are equal to or greater than Q plus 5%; otherwise, the sample proceeds to the second stage.Second Stage: The average of twelve units must be equal to or greater than Q, with no unit falling below Q - 15% to pass; if not, it progresses to the final...
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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Related Experiment Video

Updated: Jul 17, 2026

Application and Methodology of the Non-destructive 19F Time-domain NMR Technique to Measure the Content in Fluorine-containing Drug Products
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Fluconazole preparations on the Belgian market: a comparative study.

K De Braekeleer1, C Fierens, J Corthout

  • 1Service de Contrôle des Médicaments - Dienst Geneesmiddelen-onderzoek, rue Stévin, 137, B-1000 Bruxelles.

Journal De Pharmacie De Belgique
|February 1, 2007
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Summary

Fluconazole capsules met quality standards in dissolution and assay tests. All tested products were pharmaceutically equivalent, aligning with European and US Pharmacopoeia guidelines.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Quality Assessment

Background:

  • Fluconazole is a widely used antifungal medication.
  • Ensuring the quality of generic drug formulations is crucial for patient safety and therapeutic efficacy.

Purpose of the Study:

  • To evaluate the pharmaceutical equivalence of fluconazole capsule preparations.
  • To assess compliance with established quality standards and pharmacopoeial requirements.

Main Methods:

  • In vitro dissolution testing of fluconazole capsules.
  • Assay testing using previously validated analytical methods.
  • Evaluation based on European network of Official Medicines Control Laboratories (OMCLs) guidelines.

Main Results:

  • All examined fluconazole capsule preparations passed all conducted quality tests.
  • The results met the stringent requirements set forth by the European and US Pharmacopoeia.
  • No significant deviations were observed in dissolution profiles or drug content.

Conclusions:

  • The evaluated fluconazole capsule preparations can be considered pharmaceutically equivalent.
  • These findings support the interchangeability of the tested fluconazole products.
  • The study confirms adherence to international pharmaceutical quality standards.