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This is no big secret: your words and deeds convey who you are. Human communication a

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

nd behavior drop into three essential groupings: Passiveness; Aggressiveness; Asserti

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

Examples of combination products may in

veness.

Passiveness is an unwillingness or incapacity to confidently communicate wha

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

t you think and feel. Decades back, our society rewarded women for being passive and

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

men for being aggressive. Now as more and more women express their trepidation in the

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

Combination pro

workplace, this is shifting.

Aggressive communication, whether direct or indirect,

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

outcomes in a put-down of the other person, making her feel offended, defensive and m

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

rtified. Aggressive behavior fails to take the other person’s aims or feelings into c

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

onsideration. Only the aggressor’s goals are satisfied. This often spawns bitterness

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

and aggravation that later returns as opposition and rebellion. Recall a time when so

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

meone chose aggressive communication at the expense of another person. Now imagine ho

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

Following aspects would a

w would you feel about approaching such a person? Aggression bullies, humiliate and s

dd to the challenges in developing combination products:

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

hames another person.

Assertiveness poses an alternative to the extremes of passiven

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

ess and aggressiveness. It demands confidence in articulate what you think, feel and

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

elieve, defending your rights while respecting the rights of others. Assertion finds

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

power in respect: respect for yourself and for the other person. People have a tenden

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

Professional from academic institutions, pharmaceutical industries, health care indust

cy to cooperate when they are approached or advised in a way that respects the requir

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

ements of both parties. Assertive communication often allows both persons to attain t

.

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

heir desires.

The next time you feel small and want to cower, just remember you have

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

Companies that provide selfless information through particip

a choice. You can choose to be steamrollered. Or you can choose to get what you want

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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