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Adolescence is an important period of one’s life. Adolescence is in fact the sine quo’on of life. Adolescence is like a bridge between the sta

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 of infancy and adulthood. It is during this stage of adolescence that varied changes takes place in one’s body both physical and psychologi

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

Examples of combination products may in

cal. Adolescence is the transitional period of human growth and development. The group of people who falls under the stage of adolescence is c

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

alled the adolescents. Adolescents also witnesses various physiological and biochemical changes in their body. Adolescence normally covers the

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

age group from 12 to 18 year. Because of the varied changes which occur in one’s body during adolescence different emotions crops up in the a

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

Combination pro

dolescents. Depressions, tensions, restlessness and certain other emotions are quite visible during adolescence. Adolescence is stated by an A

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

merican psychologist as the period of “storm and stress of one’s life.”

Physical changes during adolescence are known as puberty. Adolescent

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

girl’s experiences menstruation during this stage. Adolescent boy’s experiences seminal emission. Further, adolescents also experience sudden

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

bodily changes like growth of pubic hair in different parts of the body like under arms etc. Adolescent boy’s also experiences sudden change i

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

n their voice. It is to be noted here that during adolescence the young boys and girls gets more attached towards each other. They become more

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

curios to know about the opposite sex. This curiosity may thus create some unwanted problems. Thus adolescence is a stage which needs proper

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

Following aspects would a

care and guidance.

Adolescence experiences growth in height and weight. Adolescents are virtual hero worshippers. They choose their own ideal

dd to the challenges in developing combination products:

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

in their life that they consider it as their ideal source and thus follow the path as has been laid out by their ideal hero. Adolescents are

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

moreover socially conscious people. They cannot stand any injustice meted out to them. It is necessary to be noted out here that juvenile deli

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

nquency is found to be very prone during the stage of adolescence. More particularly it is found that adolescent boys and girls are delinquent

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

s who very often don’t opt for the rules of the society and on the basis of which they are tried in the juvenile delinquent court. Further, ad

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

Professional from academic institutions, pharmaceutical industries, health care indust

olescents are found to develop the craze of sex in their life.

Thus adolescence when verified is found to be a very important period which ne

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

eds proper guidance. So adolescent’s parents should provide proper source of help and guidance to their children. Knowledge of sex should not

.

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 hidden from them but should be made known to them so that they do not carry any misconception of sex in their life. The sexual instincts of

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

Companies that provide selfless information through particip

the adolescents should thus be stimulated through certain creative works which they can include as their hobby or extra-curricular activities

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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