E-Articles - Health and Fitness

Social anxiety is an anxiety disorder in which there is intense fear of social events and interaction with people. A pe

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

rson with social anxiety disorder suffers from embarrassment, humiliation, depression, inadequacy and fear of performin

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

Examples of combination products may in

g poorly in a social situation. The most common situations in which people experience significant emotional distress ar

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

speaking in public, being the center of attraction, meeting new people, talking to a person of the opposite sex, writi

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

ng in front of others, or being watched by others.

When exposed to these situations, a person with anxiety disorder ma

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

Combination pro

become very uncomfortable and can experience physical and emotional symptoms. Emotional symptoms include intense fear,

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

feeling of wanting to escape and nervousness, while the physical symptoms include palpitations, sweating, dizziness, 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

ense muscles, flushing/blushing and trembling. In extreme cases of social anxiety disorder, a person may rely on alcoh

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

l or drugs to get him through the dreadful situation.

Although the exact cause of social anxiety has not been establis

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

hed, it is apparent that both biological and psychological factors play an important role. Genetic predisposition is a

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

ause for social anxiety. Sensitivity to criticism, shyness and behavioral inhibition may be passed on from one generati

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

Following aspects would a

on to the other. A person with one or both shy parents may inherit a genetic code that turns shyness into social anxiet

dd to the challenges in developing combination products:

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

y.

A combination of genetics and environment triggers the social anxiety disorder. Social anxiety emerges at differen

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

stages of development. Any traumatic, insulting or stressful life events, occurring in the early developmental stage,

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

may increase the chances of social anxiety disorder. It may also be caused due to certain imbalances in the brain chemi

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

als called serotonin, which helps in transporting signals between the nerve cells in the brain. These chemical messenge

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

Professional from academic institutions, pharmaceutical industries, health care indust

rs help in regulating a person's thoughts and feelings. Any imbalances in these create a problem with the way the brain

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

's messages are sent out and a person feels depressed or anxious.

Another cause of the anxiety can be the disturbances

.

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

of amygdala. Amygdala is the small structure in the brain that controls fear response. An overactive amygdala can cause

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

Companies that provide selfless information through particip

social anxiety. Individuals with social anxiety disorder have disturbances in some part of the anxiety response system

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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