Answers - Real Estate

How many times have you dreamed about having that perfect home? You picture the entry with white and black checker board tile on the floor, which opens to the foyer facing the split staircase. How

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

many times have you imagined yourself in front of the fireplace in the family room with a vaulted beam ceiling?

You know in your mind every inch of the perfect kitchen. A kitchen that has superb

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

Examples of combination products may in

ly finished oak cabinets and granite counter tops; the center island with a cook-top and breakfast bar on the back side with beautiful wood stools. You've designed over and over in thought and dre

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

am how the professional stainless steel range set in the perfect spot with plenty of counter space and all the other appliances in just the right space will look and feel.

More and more the thoug

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

ht of a small conservatory off of a den is speaking to your inner being. The soft warmth of a plush master bedroom with master bath, and oh that whirlpool tub.

And then you fall into that pattern

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

Combination pro

of thinking that there is no way on your family income could you ever afford a home like that. Well, that dream home may be closer then you think. Closer and more affordable without having to mak

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

e a lot of concessions, or give up all those nice aspects, because building it might be a lot cheaper then you think

First off, let's get that old concept of modular homes out of your mind. The o

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

ne where you see that rectangular home split in two halves going down the highway kind of concept. Is that a modular home? Technically yes, but modular homes have progressed so much farther in the

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

past decade that the old spit-it-in-two type modular home is a distant relative of the modern custom designed and constructed modular homes of today.

Let's look at the term modular. Something is

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

modular if it includes or uses modules which can be interchanged as units. Modular homes of the past were built from standard floor plans usually Then the home was constructed in a factory usuall

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

using a modified one piece construction, split in two, and shipped out to the erection site location. What's modular about that? Not much in my opinion.

Today's modular homes are built truly fro

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

Following aspects would a

m modules. The larger the home plan is, the more modules that will be incorporated into it. Each module can be split out of the over all design and replace with another for the most part.

Sure th

dd to the challenges in developing combination products:

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

ere are some constraints, but with computer aided design the building of modular homes is better able to make a home buyers ideal design take place. By plugging in pre-designed rooms or spaces one

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

at a time the computer can formulate a plan that follows input design to a much greater extent then every before. More so the computer can allow the buyer to pick the rooms or spaces they want in

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

corporated into a design allowing the program to select those finished designs that best utilize chosen design aspects.

Because most of all the work of construction including plumbing and electri

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

cal is done under controlled conditions, there are no construction design surprises halfway through the completed project. With the aid of the computer, the buyer knows right from design inception

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

Professional from academic institutions, pharmaceutical industries, health care indust

if there will be problems with structural layout. Elaborate designs that were once only able to the very wealthy who could afford to hire top flight architectural firms to work with construction

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

crews during construction, are now available to almost everyone.

Then after the plan is formulated, the modules are assembled by design to be transported to the work site, where they will be asse

.

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

mbled by a crew proficient in on site modular construction. It is not uncommon to have a Modular home delivered to the erection site in 4, 5 or more modules to be assembled.

So you see the "Modul

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

Companies that provide selfless information through particip

ar home" has come into its own, and fulfilled its mission concept of truly making homes modular. But more over it has helped to make the American dream of the perfect home that much more obtainabl

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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