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You have built a successful Internet based home business and your revenues are rolling in, so why should you worry about contingency plans? After

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

all the Internet is ubiquitous and available virtually all over the world. We will examine some of the single points of failure, which could ser

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

Examples of combination products may in

ously damage your revenue stream in this article about contingency plans.

There are literally thousands if not millions of Internet businesses t

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

day and we cannot anticipate every possible scenario. Instead this article will discuss some of the general areas that anyone who depends on the

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

Internet for their revenue should consider. Single points of failure are really the central focus of any contingency planning. Any time you have

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

Combination pro

failure of one of these elements, you can seriously risk your revenue stream and service to your customers.

The Internet itself is widely avail

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

ble with many interconnecting routes for managing traffic and as a result is one of the most robust networks available on the planet. So what is

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

the problem? Well everyone must access the Internet from some point regardless of whether you do it from your home or office. In addition the ser

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

ices you use to provide your service to your customers must also access the Internet as well. These access points and applications, which run on

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

hese servers are often the trouble spots for many people.

Lets assume that you have a high speed line coming into your home with several compute

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

s and employees working on them and using this high speed line. What happens if you have computer failures, your hard disk fails or your high spe

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

Following aspects would a

ed line goes down for a day. Do you have back up plans in place to replace your computers, to work from another location or recover your lost dat

dd to the challenges in developing combination products:

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

. Depending on the risk of these events occurring and the impact on your revenue, you may want to implement recovery programs that minimize the i

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

pact of these sorts of failures.

At the other end of the network you are most likely making use of some ones server farm and applications that a

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

re running on these servers. This area is even more important since if your revenue stream is dependent on these applications running you will wa

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

t to make sure that they can survive any number of catastrophes. Questions you can ask include: is the data backed up every day; do they have bac

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

Professional from academic institutions, pharmaceutical industries, health care indust

up servers that your applications can be migrated to if there is a failure; do they have back up power to deal with power failures; do they have

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

several access points to the internet in case one line goes down; are their databases secure from hackers; etc.

These are just a few of the are

.

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

s that should be considered as part of your contingency planning activity. Of course you must balance cost vs. revenue loss with the risk of fail

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

Companies that provide selfless information through particip

res to decide on how much should be spent to deal with a potential disruption to your Internet based home business.

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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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