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Q. My husband and I have a problem when it comes to spendin

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

g time together. He thinks we have spent time together if we have

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

Examples of combination products may in

watched a movie or TV show or taken a walk together. How can we

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

be together if we don't have any time to talk while we're togethe

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

r? I want to talk and find out what he is thinking and feeling. W

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

Combination pro

hat can we do?

A. WARNING!: I am about to make tw

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

o sweeping generalizations.

I realize the danger in doing this,

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

but here goes anyway:

In general, men get their togetherness nee

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

ds met through companionship; women get their togetherness needs

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

met through connection.

Two guys can spend the day together, pla

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

y racquetball and then watch a game on TV, and hardly say 10 word

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

Following aspects would a

s to each other. Yet they will report that they have had a wonder

dd to the challenges in developing combination products:

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

ful time.

Two women can spend the day together, and the only way

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

they won't communicate is if they are mad at each other or are m

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

other and daughter, or both.

The trick is to be able to meet bot

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

h needs for togetherness. The best and fastest way I have found t

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

Professional from academic institutions, pharmaceutical industries, health care indust

o do this is involves three steps:

1. He makes a list of what co

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

mpanionship togetherness looks like to him.

2. She makes a list

.

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

of what connection togetherness looks like to her.

3. Make sure

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

Companies that provide selfless information through particip

the two of you do some things from each list on a regular basis.

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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