Tags |
|
|
Links |
|
|
Advice Pool - Standards Ruling Our Lives
When you have bought a new TV you expect the plug to fit the socket. When you buy a video disk you expect it to fit your recorder. When you buy a
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
new tire, you would like it to fit the wheel. When you write a document you want it to open on another computer with a different word processor.
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
Yet:
A video game fits only the device it is made for: Xbox, PSP, Play Station, PC and Nintendo. They are all different. Exchanging software an
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
hardware between them is limited or even made (deliberately) impossible.
But, on the other hand:
XML is a new standard that has been developed
But, on the other hand:
XML is a new standard that has been developed
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
to facilitate the exchange of information through the internet. Before the internet, companies also did exchange information but by means of a m
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ch more closed and exclusive Electronic Data Interface (EDI) format.
Web services are also going into the direction of a standardized way to del
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
ver an automated function. Agreed by the web world and therefore a powerful medium to exchange services.
Before we are able to examine the impor
Before we are able to examine the impor
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
tance of standards and the way they affect our lives we should search for specific characteristics of each standard. This could be done by an inv
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ntory of the different types of standards. This will lead us to the authority on standards. The international Standardization Organization: ISO (
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ww.iso.org)
To give same idea about the areas where standards are used, look at this catalogue (www.iso.org/iso/en/CatalogueListPage.CatalogueLi
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
t) A part of the catalogue is shown below. This means that every area has its own standards:
- 65 Agriculture
- 49 Aircraft and
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
space vehicle engineering
71 Chemical technology
...
29 Electrical engineering
31 Electronics
2
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
Energy and heat transfer engineering
...
1 Generalities. Terminology. Standardization. Documentation
81 Glass and
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
eramics industries
11 Health care technology
37 Image technology
35 Information technology. Office machines
<
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
li>25 Manufacturing engineering
...
7 Mathematics. Natural Sciences
3 Services. Company organization, management an
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
quality. Administration. Transport. Sociology
33 Telecommunications. Audio and video engineering
If we look at the l
If we look at the l
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
st we can argue that a standard has a certain scope: standards for information technology are only valid and applicable at that area. Also for te
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
lecommunications, and services.
There are also standard dedicated to safety and security (health care, aircraft and communications) whereas othe
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
are more generic, like the ones for management and quality. The former should be much more compelling than the latter.
This is only a tip of th
This is only a tip of th
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
iceberg. But why worry? Why are these standards important? They are because standards rule our lives...and that is interesting!
© 2006 Hans Boo
© 2006 Hans Boo
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.advicepool.org.ua/article/22114/advicepool-Standards--Ruling-Our-Lives.html">Standards Ruling Our Lives</a>
BB link (for phorums):
[url=http://www.advicepool.org.ua/article/22114/advicepool-Standards--Ruling-Our-Lives.html]Standards Ruling Our Lives[/url]
Related Articles:
Turning Chaos Into Calm: Creating Your Productive Environment
Bookmark it:
|