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It doesn’t matter what kind of relationship you are in. Expectations on the part of the people in the relationship play a lar

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

ge part in determining the health of that relationship. Take an employee-employer relationship for example. An employee that

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

Examples of combination products may in

does not live up to what his employer expects will likely find himself fired.

The same dynamic is in full effect in our rom

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

ntic relationships. Say your date is expecting you to take her our to a nice dinner. Hopefully you didn’t mean diner, because

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

she will be disappointed, and that can be a problem.

Where do expectations come from ? They come from a variety of places.

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

Combination pro

hen it comes to romantic relationships a common driving force is what I call a person’s “inventory of experiences.” Much of t

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

his comes from what a person observed of their parent(s) growing up. Even in this day if a man grew up in a home with a fathe

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

that didn’t help around the house, he may expect to come home and leave the housework to his spouse. If his wife grew up in

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

a two career home where the father took an active role in the household chores she may expect the husband to do likewise. Obv

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

ously if these different expectations are important enough to one or both members of the couple this can be a major problem !

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

In a business relationship if a merchant has a hard-line about his 30 day return policy, it can be a problem for a customer

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

Following aspects would a

who has an expectation that the merchant will resolve any problem he has with the product.

Expectations are probably the bi

dd to the challenges in developing combination products:

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

gest danger when two people in a relationship have conflicting expectations. In this situation one person or the other has to

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

give up all or most of what they expect. This can be hard for someone to do. Take our example couple above. If he expects t

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

do no housework, and she expects him to do half, he is not willing to do any, and half may be her minimum. This leaves littl

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

e room for compromise. The consequences for their relationship can be severe.

In the case of conflicting expectations a grea

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

Professional from academic institutions, pharmaceutical industries, health care indust

deal of maturity may be required of one or both people in the relationship. One or both parties will have to decide that the

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

relationship is more important than their expectation.

Next time you are in a relationship that is showing some strain, try

.

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

to see if the other side is expecting something different than you. If so try to understand why they expect things to go diff

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

Companies that provide selfless information through particip

erently. Wherever possible put your relationship before any of your expectations. Your relationships will be stronger for it

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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