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Related Concept Videos

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

Pharmaceutical products contain more than just the active drug; they also contain various excipients such as binders, solubilizers, stabilizers, preservatives, and other elements. In some cases, impurities or contaminants might be present. Traditionally, quality control in pharmaceuticals has primarily focused on the analysis of the active drug, often overlooking the impact of these additional components. The recent issue with heparin contamination by over-sulfated chondroitin sulfate, a...
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Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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.
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...
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,...
Bioequivalence: Overview01:16

Bioequivalence: Overview

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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[Counterfeit pharmaceuticals in Peru].

Luis E Moreno Exebio1, Javier Rodríguez, Freddy Sayritupac

  • 1Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Perú. lemoreno70@hotmail.com

Revista Panamericana De Salud Publica = Pan American Journal of Public Health
|March 27, 2010
PubMed
Summary
This summary is machine-generated.

Counterfeit pharmaceuticals increased annually from 2005-2008, with national brands and tablets most affected. This sophisticated forgery poses a significant public health risk, particularly for essential medicines.

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Area of Science:

  • Pharmacovigilance and Pharmaceutical Quality Control
  • Public Health and Drug Safety
  • Medicinal Chemistry and Formulation Analysis

Context:

  • The National Quality Control Center (Centro Nacional de Control de Calidad - CNCC) in Peru monitored pharmaceutical quality.
  • A significant rise in counterfeit drugs was observed between 2005 and 2008.
  • Counterfeit medications represent a critical challenge to global health security.

Purpose:

  • To quantify the prevalence of counterfeit pharmaceutical drugs detected by the CNCC from 2005 to 2008.
  • To identify the types and characteristics of these counterfeit drugs.
  • To analyze trends in pharmaceutical product forgery within Peru.

Summary:

  • Counterfeit drug prevalence rose from 3.0% in 2005 to 9.2% in 2008, with an average annual variation of 45%.
  • Key counterfeit categories included alimentary tract/metabolism (34.5%), anti-infectives (21.1%), and nervous system drugs (17.1%).
  • Common forgeries involved correct active ingredients with incorrect manufacturers (62.4%) or absent active ingredients (22.4%), predominantly in national brands (61.0%) and tablet formulations (66.0%).

Impact:

  • The findings highlight a growing threat to public health due to sophisticated drug counterfeiting.
  • The prevalence of counterfeit anti-infectives underscores the potential for widespread treatment failures and antimicrobial resistance.
  • This study informs regulatory bodies and healthcare providers about the evolving landscape of pharmaceutical fraud.