E-Articles - Health and Fitness

The potential threat of an influenza pandemic due to the H5N1 avian influenza virus has gained the attention of agencies and

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

governments worldwide. Outbreaks of avian influenza (AI), once limited to East Asia, have spread rapidly to wild birds and f

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

Examples of combination products may in

owl in Eastern and Western Europe, as well as Africa in a matter of months. Human cases of AI have increased dramatically as

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

well, raising concern that the H5N1 virus could soon become transmissible by human-to-human contact. As of August 17, 2006,

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

the cumulative number of confirmed human cases of avian AI reported to WHO was 239, of which there were 140 deaths.

The Ban

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

Combination pro

k has worked as part of a coordinated team, including WHO, OiE, FAO, the UN System Influenza Coordinator (UNSIC), since the b

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

eginning of these AI outbreaks to aid in developing and financing preparedness and response plans for a potential avian and h

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

uman influenza (AHI) pandemic. Following a conference in Geneva in November, the Bank, along with the Government of the Peop

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

le’s Republic of China and the European Commission, organized the International Pledging Conference on Avian and Human Pandem

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

ic Influenza January 17–18 in Beijing. A Multi-donor Financing Framework to help meet financing needs and gaps was welcomed

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

in Beijing with donors making pledges of US$1.9 billion to assist countries currently affected by or at risk for avian influe

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

Following aspects would a

nza. Since that meeting, a Multi-donor Trust Fund for Avian Influenza and Human Pandemic Influenza was established by the Ba

dd to the challenges in developing combination products:

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

nk in late Spring 2006.

The Avian and Human Influenza (AHI) Facility is a trust fund facility established at the World Bank

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

to assist countries in meeting financing gaps in their AHI integrated country programs to minimize the risk and socioeconomic

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

impact of avian and possible human pandemic influenza. The AHI Facility will be available to cofinance operations supported

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

by the World Bank or its concessional financing affiliate, the International Development Association (IDA), under the US$500

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

Professional from academic institutions, pharmaceutical industries, health care indust

million Global Program for Avian Influenza (GPAI), which by the World Bank’s Board endorsed in January 2006. In countries whe

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

re the Bank is not active or other agencies take the lead role, the AHI Facility can provide self-standing grants or cofinanc

.

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

ing for other agencies’ programs. The AHI Facility can also provide grants to international organizations and to nongovernmen

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

Companies that provide selfless information through particip

tal organizations. As of May 23, 2006, seven donors have confirmed equivalent to about US$69.3 million for the AHI Facility.

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.e-article.org.ua/article/241764/e-article-Avian-Influenza-Continued.html">Avian Influenza (Continued)</a>

BB link (for phorums):
[url=http://www.e-article.org.ua/article/241764/e-article-Avian-Influenza-Continued.html]Avian Influenza (Continued)[/url]

Business card printing had tamed to give in significant contributions in the print and web industry. It is this medium that businesses are able to keep their clients in tact and as well as establish a remarkable corporate identity in the market. Business card printing companies had cluttered to give in valuable solutions from the smallest detail of your cards from logos, design and informative contents.

Email marketing is one of the most exciting things I do online. Email marketing is the lifeblood of my business – it is where I make my money. But one of the most important things about email marketing is that people have to be willing to open your emails, read them, and buy from them-

Want a Digital Camera, but need the facts? Take it from someone who know Digital Photography, it is easier than ever to get digital!

Tags

Links

E-Articles - Avian Influenza (Continued)

Related Articles: