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Related Concept Videos

Drug Regulation01:25

Drug Regulation

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

Drug Products: Biologics, Biosimilars and Interchangeables

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...
Oral Drug Delivery Systems: Continuous-Release Systems01:26

Oral Drug Delivery Systems: Continuous-Release Systems

Continuous-release drug delivery systems offer a strategic approach to maintaining therapeutic drug levels over extended periods following oral administration. By modulating the release rate of active pharmaceutical ingredients, these systems minimize fluctuations in plasma concentrations, which enhances clinical efficacy and reduces the need for frequent dosing. Such characteristics make them particularly advantageous in managing chronic diseases where patient adherence and stable drug...
Drug Nomenclature01:17

Drug Nomenclature

During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that the same...

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Related Experiment Video

Updated: Jun 5, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

[New drugs: money-back guarantee?].

Adri Steenhoek1, Marc A Koopmanschap, Margreet G Franken

  • 1Erasmus Universiteit Rotterdam, Instituut Beleid & Management Gezondheidszorg, Sectie Gezondheidseconomie, Rotterdam, the Netherlands. steenhoek@bmg.eur.nl

Nederlands Tijdschrift Voor Geneeskunde
|January 26, 2011
PubMed
Summary

New medical technologies require evaluating uncertainty against societal value. Mandatory follow-up studies and performance-based payments can mitigate risks associated with unproven efficacy and safety.

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Last Updated: Jun 5, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Failure of Cleaning Verification in Pharmaceutical Industry Due to Uncleanliness of Stainless Steel Surface

Published on: August 11, 2017

Area of Science:

  • Health Economics
  • Pharmacoeconomics
  • Medical Technology Assessment

Context:

  • New medical technologies, including pharmaceuticals, enter markets with inherent uncertainty regarding their true value and societal impact.
  • Initial market entry often grants technologies the benefit of the doubt due to incomplete data on efficacy, safety, and efficiency.
  • Post-market surveillance and follow-up investigations are crucial but frequently lack mandatory enforcement or proactive initiation.

Purpose:

  • To advocate for a structured approach to evaluating new medical technologies.
  • To propose mechanisms for reducing uncertainty surrounding the performance of new drugs and medical technologies.
  • To explore financial incentives or penalties tied to real-world outcomes.

Summary:

  • The introduction of new medical technologies necessitates a careful balance between initial uncertainty and demonstrated societal value and demand.
  • Current practices often allow new technologies to proceed with insufficient follow-up, leading to potential risks.
  • Implementing specific measures, such as financial incentives or penalties, can encourage rigorous post-market evaluation of efficacy, safety, and efficiency.

Impact:

  • Establishes a framework for more responsible innovation and adoption of medical technologies.
  • Promotes greater accountability for manufacturers regarding the real-world performance of their products.
  • Suggests a novel approach to reimbursement models that aligns payments with proven clinical and economic benefits.