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Well to answer that question, one must ask another question, i.e who best unders

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

tands a woman’s problems. It can only be a woman. The woman who was the inven

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

Examples of combination products may in

or of dishwasher happened to be a socialite, constantly beleaguered by probl

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

ms of chipped china at the hands of careless servants.

Invented in 1886 by Jose

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

hine Cochrane, the commercial production of the dishwasher was started after 189

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

Combination pro

. The invention of the dishwasher is the culmination of efforts to

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

eliminate human error in the carrying out of mundane tasks like dish washing, wh

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

ch although monotonous requires alertness and careful and delicate handling. And

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

of course, inventing the dishwasher makes practical sense, allowing dishes to be

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

washed together in one go and with minimal water, with water consumption alone e

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

timated to be half of what would be required when washing them by hand. Dish was

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

Following aspects would a

ers also provide convenient storage of the dirty or used dishes, until it is rea

dd to the challenges in developing combination products:

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

y to be washed.

Modern dishwashers also have “rinse and hold” cycles, that runs

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

a summary wash/ rinse of the dishes to eliminate excessive food particles, and s

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

oring them until such time that the machine is fully loaded to clean in one go.

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

b>Dishwashers also facilitate a more hygienic cleaning with near boiling wat

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

Professional from academic institutions, pharmaceutical industries, health care indust

r, while also drying the dishes with hot air, a technique that not only saves on

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

the time normally required when individually drying dishes one by one. The dishw

.

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

sher is a woman’s answer to the challenge thrown to her in juggling with separat

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

Companies that provide selfless information through particip

roles as a housewife, mother, career woman, entertainer, socialite and what not

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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