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Modular construction, also called prefabricated construction, is mainly of two types: mobile of

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

fices and modular buildings. Mobile offices are generally supply buildings used by construction

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

Examples of combination products may in

companies for temporary office space while modular buildings are custom-built as per the user's

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

specifications.

Modular buildings are constructed in a factory-controlled environment using th

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

same materials that are used for traditional buildings. The floor plan of the building is brok

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

Combination pro

n up into individual modules. The size of the module generally ranges in size from ten to eight

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

en feet in width and thirty six to seventy six feet in length.

Almost ninety percent of a modu

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

lar building is factory-made. Each module is built with walls and ceilings. They are also fitte

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

with carpets and wiring is done initially. A seamless building is assembled from the building

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

odules when they reach the site. Most modular buildings consist of one or two modules.

Modular

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

buildings can be used for different purposes. Schools, classrooms, daycare centers and dormitor

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

Following aspects would a

es are being built. Modular construction is also used to build office buildings, clubhouses and

dd to the challenges in developing combination products:

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

health care facilities.

There are however some design constraints in case of modular buildings

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

As the building is shipped via road, height of the modules is a major constraint. The modular

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

buildings generally have a height of around eight feet unlike traditional construction, which c

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

n go up to a height of nine or ten feet. It is difficult to opt for modular buildings where hei

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

Professional from academic institutions, pharmaceutical industries, health care indust

ht is a problem, like in the case of riding arenas and warehouses.

There are a variety of fini

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

hes to choose from for a modular building exterior, such as wood, steel and brick. Exteriors ca

.

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

be customized using windows, multiple doors and various roof treatments. There has been a rece

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

Companies that provide selfless information through particip

t trend of constructing more permanent modular buildings that require more on site construction

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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