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The literature on assertiveness distinguishes many models, with varying validity and practical usefulness. In developing the ‘Assertiveness Coffee Cards’ we have been le

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

d to look at the issue from a different angle, namely that of how the brain functions. As a result, we propose the following classification of assertive behaviour:

1. R

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

Examples of combination products may in

eptilian Emotional Assertiveness;
2. The Learned Assertiveness Behaviour;
3. The Frontal Lobes Driven Assertiveness; and
4. The Perceived Assertive Behavi

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

ur.

The reptilian emotional assertiveness derives its name from the strong influence of the amygdala that is located in the limbic system, or reptilian brain. The learn

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

ed assertiveness behaviour is largely linked to the caudate nucleus, where we store our automatic thoughts, prejudices and cognitive reflexes. The third type of assertiv

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

Combination pro

ness is produced by the frontal lobes, the place where humans hold, manipulate and construct their most sophisticated ideas. This article deals specifically with the fou

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

rth type of assertive behaviour, namely the perceived assertive behaviour. This has definitely to do with our own traits, thoughts and actions, but attention is given he

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

re to how people interpret them. Let us remember that, to some extent, ‘reality is a construction of the mind’. This framework explains why the same behaviour may be see

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

as gentle assertiveness in one culture and unacceptable lack of politeness in another.

When you communicate, you send a variety of signals that are in effect just sens

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

ory perceptions for others. But these incoming sensory perceptions get their meaning only when they are recognised by their brain. Because each brain is unique, it is li

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

ely that your messages will receive different interpretations according to the receivers’ genetic and neural makeup. Here, your own words, gesture and intonation get a s

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

Following aspects would a

ubjective meaning, reflecting the other person’s own experience, beliefs, values and prejudices. There are two types of recognition: one is the automatic type of recogni

dd to the challenges in developing combination products:

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

tion that happens when the unconscious brain recognises something is known to it; the other type of recognition happens when the incoming stimulus starts to take on iden

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

ity along the pathway that runs from the appropriate cortical sensory area to the association area that abuts it. Information is brought in from memory to flesh out sti

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

mulus with the associations that five it meaning.

A good punchline, getting a joke and recognising familiar sounds and facial expressions, understanding metaphors produ

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 what Rita Carter calls a ‘cerebral snap of the fingers’, delivering a sudden jolt of recognition. It happens so fast, even before the conscious brain has even decided

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

Professional from academic institutions, pharmaceutical industries, health care indust

what the incoming stimuli really are. Don’t we have here a golden opportunity to speak to the unconscious mind of the other? Moreover, we know that recognition is based

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

on associations. You will also gain from inducing the right associations. If you walk like Charlie Chaplin you would most probably evoke certain feelings. If you want to

.

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

be perceived as gentle but firm in defending your rights, you might want to recourse to a subtle imitation of well known and appreciated leaders. The good news is that y

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

Companies that provide selfless information through particip

our behaviour – be it an imitation – is likely to ultimately change the way you think and behave.

For further information, please visit our site at http://www.cute4u.ne

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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He was concerned with the direction a decision was leaning, Jon said on his voice mail. Could I meet him for lunch in the cafeteria before Friday's meeting to talk it through? As peer managers involved in policy implementation, our departments would be impacted by any direction taken. Friday's meeting was with the decision makers; a discussion of pluses, minuses, timetables and resources needed for three options under consideration.

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