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Are you up for the challenge of designing your own home? If you have the time and experien

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

ce, then maybe you are. Otherwise, you may want to consider hiring an architect. Whether y

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

Examples of combination products may in

ou want an architect to modify a stock home to better suit your needs, or whether you want

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

him or her to design a home from scratch based on your vision, an architect can add value

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 your home building experience. While it may seem like an added cost in the beginning, t

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

Combination pro

he experience an architect brings to the table, coupled with the fact that using one often

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

saves time, can save you money in the long run.

Architects are a dime a dozen. Just pick

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

up the phone book and you'll see what we mean. However, the perfect architect for you is a

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

little harder to find. So how do you find one that will perfectly suit your needs?

• Whe

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 you see homes that appeal to you, find out who the architect was. Or ask friends whose h

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

mes you like for recommendations.

• Surf the web. Try the American Institute of Architect

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

Following aspects would a

s, www.aia.com, for qualified architects in

dd to the challenges in developing combination products:

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

your area.

Once you've narrowed down your search and found a few architects whose design

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

abilities appeal to you, let the interview process begin. During this process you'll want

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

to find out:

• The cost of the architect.

• If the architects personality compliments yo

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

urs. For example, if you don't want to be involved in the process, is the architect and in

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

Professional from academic institutions, pharmaceutical industries, health care indust

dependent worker who doesn't mind complete control? Or, if you do want to be involved in t

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

e process, is the architect willing to include you?

• Whether the architects taste and yo

.

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

ur taste are similar.

• How much knowledge the architect has when it comes to your home's

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

Companies that provide selfless information through particip

location. An architect who knows how to handle the local bureaucracy is a treasure indeed

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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