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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

238
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.
238
Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence01:22

Pharmaceutical Alternatives: Stability-Related Therapeutic Nonequivalence

235
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...
235
Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence01:19

Pharmaceutical Alternatives: Excipients and Impurities-Related Therapeutic Nonequivalence

218
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...
218
Bioequivalence: Overview01:16

Bioequivalence: Overview

2.1K
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,...
2.1K
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

328
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...
328
Dosage Regimen: Individualization01:24

Dosage Regimen: Individualization

246
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...
246

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Related Experiment Video

Updated: Mar 8, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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Pharmaceutical Pricing: The Use of External Reference Pricing.

Kai Ruggeri, Ellen Nolte

    Rand Health Quarterly
    |January 14, 2017
    PubMed
    Summary

    External reference pricing for patented medicines shows significant global variation. Despite the UK

    Area of Science:

    • Health Economics
    • Pharmaceutical Policy
    • Drug Pricing

    Background:

    • External reference pricing (ERP), or international price comparison, is a key strategy for controlling pharmaceutical prices of patented, in-patent drugs.
    • The UK is negotiating new pricing arrangements for branded medicines from 2014, with UK prices influencing global benchmarks.
    • Understanding pharmaceutical pricing strategies in high-income countries is crucial for policy development.

    Purpose of the Study:

    • To analyze approaches to pharmaceutical pricing in high-income countries.
    • To examine the role and variability of external reference pricing in drug price determination.
    • To clarify the complexities and impact of cross-referencing practices.

    Main Methods:

    • Comparative review of pharmaceutical pricing and external reference pricing practices.

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  • Analysis of experiences in Canada, France, Germany, Italy, the Netherlands, and Spain.
  • Examination of terminology, practices, and reference basket compositions.

    • Main Results:

    • High variability in external reference pricing implementation and its relative importance across countries.
    • Considerable variation in terminology and practices related to pharmaceutical pricing.
    • Challenges in estimating the direct impact of pricing changes due to diverse ERP methods and overlapping reference baskets.

    Conclusions:

    • External reference pricing strategies exhibit significant diversity globally.
    • The international impact of UK pricing changes on pharmaceutical prices is likely minimal or indirect.
    • Clarification of terminology and practices is needed for a better understanding of ERP complexities.