Advice You - Internet and Businesses Online

Research has been undertaken into how to apply the work of Tim Berners-Lee and others in the World Wide Web Consortium (W3C) (2006b), (Berners-Lee, 1999). In order to represent informat

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

ion it is necessary to use Meta-languages. The use of standards for sharing information and resources is core to research into the Semantic Web. The Semantic Web involves making the Web

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

into a repository of knowledge, which can be catalogued and searched intelligently. Software agents could then undertake this search task. Berners-Lee and colleagues have envisaged the

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

Semantic Web as a global database with the information held in a structured form where content is separated from formatting (Berners-Lee et al 2001) and (Berners-Lee, 2002). To achieve

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

this, the structure is created using XML Meta-tags, and a stylesheet provides formatting. Stylesheets are also defined using XML. The Semantic Web should make information more understan

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

able by machines and by humans. This can help people, and intelligent agents find the information they need.

The Grid and Semantic Web areas of research are converging. The ideas and t

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

echnology behind the Grid are explained in (Foster et al, 2001a) and (Foster et al, 2001b). Universities are involved in Grid-computing research, Southampton (De Roure et al 2001a) and

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

(De Roure et al, 2001b), Exeter, Liverpool John Moores (Alan et al, 2003) and (Naylor et al, 2003). Semantic Web and Grid researchers have recently become involved in the Semantic Grid.

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

The Semantic Grid involves sharing of computer resources as well as information, and does not just apply to high performance computing applications. Semantic languages and ontologies ca

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

n be part of a larger effort to provide a Grid of information and applications, which can be requested as required. If a user requests the answer to a problem using one computer, this c

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

n then get the help of others to solve it. Machine intelligence does not then reside in one machine but in the complex system of interacting machines.

References

Allan, A., Tay

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

lor, T., 2003. eSTAR:Telescopes and Databases as a Single Information Grid, Toward an International Virtual Observatory. Proceedings of the ESO/ESA/NASA/NSF Conference, Garching, German

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

y, 10-14 June 2002, ESO Astrophysics Symposia. ISBN 3-540-21001-6. Springer-Verlag Berlin/Heidelberg, pp 167.

Berners-Lee, T., 1999. The future of the Web http://www.w3.org/Talks/1999/

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

414-LCS35-tbl/slide1-1.html.

Berners-Lee, T., Hendler, J., Lassila, O., 2001. The Semantic Web. Scientific American, May 17, 2001.

Berners-Lee, T., 2002. The World Wide Web - Past Pre

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

sent and Future http://www.w3.org/2002/04/Japan/Lecture.html, Japan prize Commemorative Lecture.

De Roure, D., Baker, M. A, Jennings, N. R., Shadbolt, N. R., 2003. The Evolution of the

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

Grid, Southampton University.

De Roure, D., Baker, M. A., Jennings, N. R., Shadbolt, N. R., 2003. The Semantic Grid: A Future e-Science Infrastructure, Southampton University.

Foster,

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

I. Kesselman, C. Tuecke, S., 2001. The Anatomy of The Grid. International Journal of Supercomputer Applications, Argonne National Laboratory, University of Chicago, University of South

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ern California.

Foster, I., Kesselman C., Nick, J. M., Tuecke, S., 2001. The Physiology of The Grid, Argonne National Laboratory, University of Chicago, University of Southern Californ

.

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

a.

Naylor, T., Steele, I., Carter, D., Allan, A., Etherton, J., Mottram, C., 2003. eSTAR Building an Observational GRID. Astronomical Data Analysis Software & Systems (ADASS) Conferenc

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

e ASP Conference Series, 2003, Exeter University, Liverpool John Moores University, 295.

World Wide Web Consortium (W3C), 2006, Leading the Web to its Full Potential http://www.w3.org/

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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