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The strong-willed, out-of-control kid is 100% successful at getting your attention -- whether it's positive attenti

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

on or negative attention!

He enjoys energy and attention. He seeks energy and attention from you too (e.g., your b

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

Examples of combination products may in

eing animated, arguing, lecturing, getting angry, threatening him, etc.). Unfortunately, he has discovered that you

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

are much more energetic, attentive and interesting when he misbehaves.

Attention-seeking children are not out to g

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

et you as a parent -- they are out to get your energy, intensity and attention. They want you to be exciting to the

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

Combination pro

m. Unfortunately, you are much more exciting when things are going wrong.

So, whenever you use a "traditional" par

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

nting strategy (like arguing, lecturing, getting angry, threatening), it is actually a reward to your kid -- he get

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

s what he wants -- your energy and attention! He is able to push your energy-producing buttons... AND THIS IS EXCI

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

TING TO HIM !

Therefore, try very hard not to show any emotion when reacting to the behaviors of your intense, att

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

ntion-seeking kid (put on your best "poker face"). The worst thing to do with this kid is to react strongly and emo

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

tionally. This will just make her push you that same way again. You do not want the kid to figure out what really b

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

Following aspects would a

ugs you. You want to try to remain as cool as possible while she is trying to drive you over the edge. This is not

dd to the challenges in developing combination products:

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

asy. Once you know what you are going to ignore and what will be addressed, it should be far easier not to let your

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

feelings get the best of you.

Points to consider:

· Destructiveness and disagreeableness are purposeful in the i

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

ntense, out-of-control teenager.

· They like to see you get mad.

· Every request can end up as a power struggle.

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

· Lying becomes a way of life.

· Getting a reaction out of others is the chief hobby.

· They are rarely sorry for

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

Professional from academic institutions, pharmaceutical industries, health care indust

the hurtful things they say and do.

· They often believe nothing is their fault.

· They try to make outsiders be

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

lieve that the entire fault lies with the parents.

· They try to make parents believe that teachers are mistreatin

.

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

them.

Thus, provide a lot of intensity when things are going right, but provide little to no intensity when thing

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

Companies that provide selfless information through particip

s are going wrong. This will greatly diminish the “negative-attention-seeking” behavior of your strong-willed child

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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