Biomedical Engineering Reference
In-Depth Information
3
Nanoparticles: New Medical
Potential—
Today and Tomorrow
Tamar Chachibaia
CONTENTS
3.1 Introduction .................................................................................................. 43
3.2 Health Monitoring Issues Concerning Nondestructive Use of
Nanoparticle Gold Compounds in Medicine and Cosmetology .......... 44
3.3 Summary ....................................................................................................... 50
References ............................................................................................................... 51
3.1 Introduction
The history of drug formulations that rely on nanoengineering is quite mod-
ern. The launch of products incorporating nanostructure particles is showing
clear differentiation across sectors. Materials and products based on nano-
technology are regulated today within the existing network. Nanostructures
are evaluated as “chemicals with new uses” or as “new chemicals.”
Health-care and life sciences applications, such as nanostructured medi-
cal devices and nanotherapeutics, have the longest time to market due to
sector-specific regulation. In 2004, the US Food and Drug Administration
(FDA) estimated that the proportion of all new drugs entering first-phase
trials that ultimately gain approval had fallen to 8% from a historical aver-
age of about 14%. The most common factors resulting in project failure are
lack of efficacy (25%), clinical safety concerns (12%), and toxicological find-
ings in preclinical evaluation (20%). Proposed Investigational New Drug
Application (IND) needs to follow the way to FDA and EC approval, pass-
ing through all stages of investigations lasting up to 10 to 15 years, starting
in vitro
and ending with the third phase of clinical trials with subsequent
approval of medication and pharmaceutical market entry.
The current applications of nanotechnology span a wide range of sectors.
The current niche for such applications is in the areas where there is an over-
lap between the medicine and cosmetic sectors. Many products are marketed
as a means to enhance performance for different lifestyles and age groups,
as an aid to health, beauty, and wellbeing. Although such applications are
relatively new and emergent, they appear to have started to make a global
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