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PROBLEM: After the rapid rate of change in business technology over the last ten years, many businesses and organizations find themselves with a hodge-podge of databases and applications that work only in isolation. They were purchased or designed to address a pressing need of the moment, often with little thought give

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

n to integrating these systems with the existing infrastructure.

Unfortunately, every new application brings with it new access points that must be secured to prevent malicious attacks or the accidental leak of sensitive information. For applications that communicate with other applications, an intrusion in one system means every syst

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

Examples of combination products may in

em with which it communicates is also vulnerable. Integrating and subsequently securing applications in such an environment can feel like more trouble than it is worth, especially for smaller businesses with fewer IT resources.

Likewise, replacing existing applications and data platforms with newer, more secure technologies can be pro

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

hibitively expensive. While retail software can solve some problems for those on a budget, they are frequently too restrictive in their feature set and may still require an expensive migration to be a feasible solution.

Meanwhile, the expectations of users and customers have grown to voracious proportions thanks to the ubiquity of 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

web. It is becoming truer with each passing year that to compete in business means to make your products or services available online.

SOLUTION: As it does so often, however, technology eventually provides solutions for the problems it creates. Recent trends have seen movement in favor of standardized communication me

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

Combination pro

thods and centralized security services.

In addition, an enlightened, incremental approach to the replacement and integration of legacy applications and databases can be used to keep even small businesses from falling behind the curve:

Efficiency -- No one likes to deal with piles of paper unless there is no other way. A web-

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

based solution not only streamlines established business practices, but makes services and information available from any web-enabled PC. As people become accustomed to mobile technology, they will find it increasingly unacceptable to be tied to their office in order to do business, or to be forced to make a phone call or send a paper

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

invoice to request goods and services.

Centralized security -- Providing a single sign-on point for users of diverse applications limits the number of access points into a system, thereby limiting the security vulnerabilities. Existing permissions -- such as those stored for users of a local area network -- can be used to perm

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

t or restrict access for a user based on his or her login credentials, automatically hiding applications the user is not authorized to use. Virtually any application can use such a front-end access point to control its own access on the back-end.

Incremental system replacement -- Too often, businesses opt for a complete makeov

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

er of an application that is past its prime when a simple facelift will get the job done. For those that can afford it, a shiny new system is always nice to have; for the rest of us, a piece-by-piece replacement is a great way to control costs with more precision, while still getting the most troublesome aspects of the legacy applicati

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

on replaced.METHODS: Now is a very good time to take a step toward office automation. New models of development theory are making the integration of legacy applications into a web-based strategy more viable than ever:

XML -- Though it has been around for a few years, XML (Extensible Markup Language) i

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

Following aspects would a

s really coming into its own as a means of transferring data from application to application. It can be easily understood and processed by a wide variety of languages for a wide variety of purposes. Because it is so friendly to basic HTML code, it lends itself well to the integration of diverse applications designed on a web foundation

dd to the challenges in developing combination products:

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

Central Authentication Service (CAS) -- In a CAS-based solution for authenticating users, credentials passed through a web-based login page are handled in one place for many different applications. This means logins and passwords need only be maintained in one place, making administration far easier. It also limits the access

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

into any CAS-integrated application to one point, the central login page, meaning greater security. The language-nonspecific nature of CAS means it can be used for virtually any type of application. As an added bonus, the CAS solution developed by Yale University is open source; integrating the solution is the only cost involved.

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

Rapid application development (RAD) -- Applications that required hundreds or thousands of man-hours to create initially may be redesigned for the web significantly cheaper thanks to the sophistication of RAD platforms such as Visual Basic .Net. While the relative ease-of-use of such packages has encouraged sloppiness on the part

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

of some neophyte developers, an experienced and professional developer can use the advantages of RAD to keep down costs.

Object-oriented design -- While not particularly new, an object-oriented approach to web application design makes the process of integration and upgrading existing systems far more flexible. Compartmentalizi

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

Professional from academic institutions, pharmaceutical industries, health care indust

g business rules within the objects that depend on them means a change in those rules won't require a massive amount of coding. Moreover, incremental development is aided by the reusability of objects; once a rule has been created for one project, it won't need to be re-created for the next project that uses it.SUMMAR

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

Y: Advancing to a web-based strategy for business solutions needn't be the exclusive privilege of large corporations and organizations. Indeed, the web itself is egalitarian by nature. A multitude of opportunities can be found there with an intelligent, guided approach to development. Integrating existing systems within a web-

.

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

based framework maximizes current assets and increases efficiency, especially when done in concert with an incremental upgrade system. Additionally, the centralization of user authentication tasks eases administration challenges and can be a powerful security tool; it also makes access to applications silky smooth for users. Finally, t

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

Companies that provide selfless information through particip

aking full advantage of emerging technologies that make integration easier means a solid solution is feasible even for the little guy.

Ultimately, acknowledging and responding to the demands of web-savvy users and customers is the first step toward ending up on the right side of the increasing divide between the winners and the losers

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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