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Related Concept Videos

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

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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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Quality assurance is the overarching term used to describe the activities employed to ensure the proper performance of a system. These activities can be classified into three categories: quality control, quality assessment, and internal corrective measures. Typically, these activities work cyclically: quality control is performed before and during the analysis, while quality assessment occurs during and after the investigation. Internal corrective measures are implemented based on the findings...
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Bioequivalence of Drugs: Drugs with Multiple Indications01:09

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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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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...
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Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
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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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Quality, efficacy, safety-it is not enough!

Silvio Garattini1

  • 1Istituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy. silvio.garattini@marionegri.it.

European Journal of Clinical Pharmacology
|March 9, 2021
PubMed
Summary
This summary is machine-generated.

Comparative studies are needed to evaluate drug efficacy and safety across different mechanisms of action for similar therapeutic indications. European drug approval criteria may require updates to facilitate these essential comparative drug evaluations.

Keywords:
Added valueDrugsEfficacyQualitySafety

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Area of Science:

  • Pharmacology
  • Drug Development
  • Regulatory Science

Background:

  • Current drug approval processes often lack direct comparative studies for drugs with similar therapeutic indications but different mechanisms of action.
  • Understanding comparative efficacy and safety is crucial for informed clinical decision-making and optimizing patient outcomes.

Purpose of the Study:

  • To highlight the necessity of comparative studies evaluating drugs with varying mechanisms of action but similar therapeutic uses.
  • To advocate for revisions in European legislation governing drug approval criteria.

Main Methods:

  • Review of existing drug approval frameworks and literature on comparative drug studies.
  • Analysis of therapeutic areas where multiple drugs with different mechanisms of action are available.

Main Results:

  • A significant gap exists in head-to-head comparative data for many drug classes.
  • Current European legislation may not adequately incentivize or facilitate such comparative trials.

Conclusions:

  • Comparative studies are essential for a comprehensive understanding of drug efficacy and safety profiles.
  • Adaptations to European drug approval legislation are recommended to encourage comparative research and improve therapeutic selection.