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It's been a whole lot of years since the music group Chicago sang "Just

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

You and Me."

More than thirty years later, there is still an important

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

Examples of combination products may in

principle we can lift from these lyrics to strengthen our relationships.

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

Just you and me time

Life just seems to get more and more hect

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

ic, and it doesn't look as if that is going to change anytime soon. Coup

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

Combination pro

les find it very difficult to get any alone time on a regular basis.

Ma

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

ny of the couples with whom I work spend little or no alone time togethe

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

r on a regular basis. This is one of the main ways that couples can drif

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

t from soul mates to room mates. At best they wind as partners trying to

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

get through the day.

How to get some "just you and me" time

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

Carve it out Alone time for couples does not just happen. You have t

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

Following aspects would a

o carve it out and protect it just like you would any other important ap

dd to the challenges in developing combination products:

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

pointment.

Date night Couples who have a regular date night repo

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

rt looking forward to it during the week. Knowing there is going to be t

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

ime to connect allows couples to feel connected during a hectic day to d

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

ay pace.

Trade off When you have kids, one way to get some coupl

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

Professional from academic institutions, pharmaceutical industries, health care indust

e time is to partner with another couple that you know and trust. One ni

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

ght you take their kids and they go out, and on another night they take

.

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

your kids and you go out.

Couple time is crucial for the success of a l

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

Companies that provide selfless information through particip

ong term relationship. Use these tips to get some "just you and me time.

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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