Related Experiment Video
Updated: Jun 2, 2026

08:06
The Use of a β-lactamase-based Conductimetric Biosensor Assay to Detect Biomolecular Interactions
Published on: February 1, 2018
[The recent Belgian legislation for community-pharmacists and its implementation]
Summary
Belgian pharmacies are adapting to a new Royal Decree requiring a Quality Manual. While older rules are followed, the decree
Area of Science:
- Pharmaceutical Sciences
- Health Services Research
Context:
- Post-publication survey of Belgian pharmacies following the Royal Decree of 21 January 2009.
- Focus on compliance with new quality management obligations.
Purpose:
- To assess the implementation status of the Royal Decree concerning Quality Manuals in Belgian pharmacies.
- To gauge pharmacists' awareness and perceived value of the Quality Manual requirement.
Summary:
- Most pharmacies adhere to previous obligations, but the new Royal Decree's requirements are not universally applied.
- Pharmacists are aware of the mandatory Quality Manual (effective 1 Jan 2012), with 47% seeing value beyond legal compliance.
- Awareness of the MyQualityAssistant website, designed to aid manual creation, is limited to two-thirds of participants.
Impact:
- Highlights the gap in adoption of new regulatory changes within the pharmacy sector.
- Indicates a need for enhanced dissemination and support for the MyQualityAssistant tool.
- Provides insights into pharmacist perspectives on quality management and regulatory compliance.
Related Concept Videos
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).
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
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,...
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...
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...
Biopharmaceutics and Pharmacokinetics: Overview
Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the appropriate...
Pharmacokinetics: Drug–Drug Interactions
Drug interactions occur when the pharmacological effect of one drug is altered by another substance, either enhancing or diminishing its activity. The drug whose activity is altered is known as the object drug, and the substance causing the alteration is called the agent drug or the precipitant. The net effects of these interactions are mostly undesirable, leading to decreased effectiveness or increased adverse effects. In rare cases, interactions can be beneficial, such as the enhanced...

