Related Experiment Video
Updated: Feb 27, 2026
17:16
Registered Bioimaging of Nanomaterials for Diagnostic and Therapeutic Monitoring
Published on: December 9, 2010
10.9K
Updated Regulatory Considerations for Nanomedicines.
T S Subin1, Venugopal Vijayan1, K Jaya R Kumar1
1Unit of Pharmaceutical Technology, Faculty of Pharmacy, Asian Institute of Medicine, Science and Technology (AIMST) University, Bedong 08100, Kedah. Malaysia.
Pharmaceutical Nanotechnology
|June 24, 2017
Summary
Nanomedicine offers improved drug efficacy and bioavailability. This review explores nanopharmaceutical development, addressing regulatory challenges and patient needs for advanced healthcare solutions.
Area of Science:
- Nanomedicine
- Nanotechnology in drug delivery
- Pharmaceutical sciences
Background:
- Nanomedicine utilizes nanotechnology for medicinal products, devices, and drug delivery systems.
- It encompasses antibody-nanoparticle conjugates and health products manufactured via nanotechnology.
Purpose of the Study:
- To review nanopharmaceutical types and development processes.
- To explore strategies for navigating regulatory hurdles.
- To align nanomedicine advancements with patient needs and upcoming regulations.
Main Methods:
- Literature review of nanopharmaceutical research and development.
- Analysis of regulatory landscapes and international harmonization initiatives.
- Examination of strategies for nanomaterial characterization and product registration.
Main Results:
- Nanomedicines demonstrate comparable efficacy to traditional drugs, with enhanced solubility and bioavailability at reduced doses.
- Despite challenges in characterization and regulatory pathways, some nanoproducts have achieved registration.
- International efforts are underway to harmonize regulatory requirements for nanomedicines.
Conclusions:
- This review highlights the potential of nanopharmaceuticals to meet patient needs.
- Strategies for development and regulatory compliance are crucial for advancing nanomedicine.
- Addressing safety concerns and regulatory uncertainties will facilitate broader adoption.
Related Concept Videos
01:25Drug Regulation
3.2K
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...
3.2K
01:15Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
54
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...
54
01:03Drug Control Governance: Regulatory Bodies and Their Impact
614
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...
614
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
382
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though...
382
01:28Drug Products: Biologics, Biosimilars and Interchangeables
311
Body: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...
311
01:27Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
209
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,...
209