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Related Concept Videos

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 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: 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...
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...
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...

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The Use of Pharmacological-challenge fMRI in Pre-clinical Research: Application to the 5-HT System
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[Separate pharmaceutical budgets: skating on thin ice].

Antoine C G Egberts1, Anthonius de Boer

  • 1Universiteit Utrecht, divisie Farmaco-epidemiologie en Klinische Farmacologie, Utrecht, the Netherlands.

Nederlands Tijdschrift Voor Geneeskunde
|January 8, 2011
PubMed
Summary
This summary is machine-generated.

Patient access to essential medications in the Netherlands is strained by complex pharmaceutical funding. Recent changes, including rising drug costs and shifting care responsibilities, necessitate urgent reform of drug budget distribution.

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Area of Science:

  • Health Economics
  • Pharmaceutical Policy
  • Healthcare Management

Context:

  • The Netherlands employs distinct pharmaceutical budgets for hospital, nursing home, and primary care settings.
  • Recent developments include an increase in high-cost medications, the shift of complex hospital care to primary care, and the transfer of budget authority to health insurers.

Purpose:

  • To analyze the pressures on patient access to adequate pharmacotherapy in the Netherlands.
  • To highlight the need for reconsidering the distribution of pharmaceutical budgets.

Summary:

  • Complex pharmaceutical funding structures in the Netherlands, combined with escalating drug costs and evolving healthcare responsibilities, are creating significant barriers to patient access to necessary treatments.
  • The 'postcode lottery affair' exemplifies how geographical location can determine access to expensive drugs, such as trastuzumab.

Impact:

  • Urgent reform of pharmaceutical budget distribution is required to ensure equitable patient access to pharmacotherapy.
  • This situation underscores the need for a streamlined and equitable approach to drug funding within the Dutch healthcare system.