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A person is product of his self and the manner by which his environment affects him. In all th

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

eoretical models regarding the development of a personality, the conscious person is supposed

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

Examples of combination products may in

to be motivated by internal interactions within his person. These two levels of personality in

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

teract with his environment and affect him individualistically developing his unique personali

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

y and psychological identity.

Social theories are used to understand and explain the tendenci

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

Combination pro

es, patterns or movement of both individuals and society based on the context of the social or

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

der they occur in. Socials only are able to explain aspects of behavior and may be difficult t

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

apply in a universally. A person’s psychological development may follow psychological models

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

or social behavior models but will vary greatly based on the history, anthropology, economics,

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

politics, theology and biology of the person.

The common factor of all theories regarding ps

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

chological development is that the person is central figure. The key elements that are prevale

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

Following aspects would a

nt along all the theories are the importance of cognitive development and perceptions and beha

dd to the challenges in developing combination products:

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

vioral orientation. Critical periods for psychological developmental have been identified as e

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

arly childhood and adolescence. However, there has been recent debate regarding the developmen

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

of the psychology of a person into stages. Like the concept of normalcy, the stages of psycho

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

logical development are now being studied whether they are to be used as standards or guidelin

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

Professional from academic institutions, pharmaceutical industries, health care indust

es.

One contention is that psychological development which encompasses the person: his biolog

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

, orientation and perception; and the world he moves in: the social structure, norms, traditio

.

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

ns, perceptions and environments. In this view, psychological development is considered a life

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

Companies that provide selfless information through particip

time interactive process that continues and perpetuates itself during the lifetime of a person

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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