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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

260
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.
260
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

226
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...
226
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

353
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...
353
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

244
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...
244
Pharmaceutical Poisoning: Potential Scenarios01:26

Pharmaceutical Poisoning: Potential Scenarios

80
Pharmaceutical poisoning can occur through various channels, impacting an estimated 2 million hospitalized patients in the U.S. annually with serious adverse drug responses. These scenarios encompass both therapeutic uses, such as drug toxicity, where even standard dosages can lead to severe central nervous system depression, and non-therapeutic exposures, including accidental ingestion by children, and environmental and occupational exposures.Unintentional poisonings often involve exploratory...
80
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence01:27

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

216
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,...
216

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Electronic solutions for combating counterfeit drugs.

R Hemalatha1, A Srinivasa Rao1

  • 1Department of Pharmaceutical Chemistry, Bhaskar College of Pharmacy, Hyderabad, Telangana, India.

Journal of Pharmacy & Bioallied Sciences
|August 1, 2015
PubMed
Summary
This summary is machine-generated.

Combating counterfeit drugs requires a unified approach. This paper proposes a comprehensive solution for verifying drug authenticity throughout the supply chain, linking it with unique identification to restore public trust.

Keywords:
Combatcounterfeitdrugs

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Area of Science:

  • Pharmaceutical Sciences
  • Supply Chain Management
  • Public Health

Background:

  • Drug counterfeiting is a growing global problem undermining public trust in healthcare systems.
  • Current anti-counterfeiting measures are fragmented and difficult for stakeholders to manage.
  • A zero-tolerance approach is necessary to address the alarming scale of drug counterfeiting.

Purpose of the Study:

  • To review existing drug anti-counterfeiting solutions and their limitations.
  • To propose a unified and comprehensive strategy for combating counterfeit pharmaceuticals.
  • To enhance the integrity of the pharmaceutical supply chain.

Main Methods:

  • Analysis of current drug supply chain security measures.
  • Identification of shortcomings in existing anti-counterfeiting technologies.
  • Development of a proposed comprehensive solution integrating unique identification.

Main Results:

  • Existing solutions are often implemented in a piecemeal fashion.
  • Wholesalers and resellers face challenges managing multiple disparate systems.
  • A unified system is needed, ideally with governmental support.

Conclusions:

  • A comprehensive solution is proposed to verify drug authenticity at each supply chain level.
  • Linking verification with unique identification is recommended.
  • This approach aims to create a more secure and trustworthy pharmaceutical supply chain.