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Acne vulgaris (otherwise known as pimples) affects 85% of all adolescents and young adults. This condition is now treatable and the superficial notion of waiting to ‘outgro

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

w’ acne is unnecessary and potentially damaging, both physically and psychologically. If left untreated, acne can worsen and cause permanent physical scarring as well as ps

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

Examples of combination products may in

chological damage. Because the face is the direct way we interact with the world, having lesions, pimples, blackheads or acne on the face and, later, scarring can damage th

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

teenager’s self-esteem and cause them to withdraw from social relationships and environmental interactions. The misperceived etiology of acne being due to unclean hygiene

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

is often associated with feelings of guilt, embarrassment and shame the teenager feels acutely. Oftentimes, the teenager will be over-indulging in an extreme cleansing ritu

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

Combination pro

l to ensure this is not the case, thereby aggravating the condition.

Acne affects teenagers at a time in their lives when hormones are raging, their personalities are blos

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

oming and social and emotional development comes into play. An adolescent feels enormous pressure to ‘fit in’ and be accepted. Appearance and physical attractiveness play a

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

key role in this game of peer status and social behavior. The affects of acne can be so damaging to a teenager that their self-esteem and body image are temporarily, if no

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

permanently, affected. An open discussion with your teen’s doctor or medical professional may help in giving your teenager the strength to open up about these problems. Fe

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

ales tend to grow their hair long and wear too much makeup to mask their acne, oftentimes exacerbating the condition. Boys and girls tend to avoid eye contact and withdraw

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

rom social and relationship building activities such as certain sports where undressing is necessary, too embarrassed about their condition. Taunts from other teenagers abo

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

Following aspects would a

ut their appearance can be cruel and damaging. In relationship bonding, it is a time where teenagers need positive self-image and enough self-confidence to form new friends

dd to the challenges in developing combination products:

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

ips, romances or other relationships. This may be extremely difficult for acne sufferers, fearing negative appraisal by other teenagers. They will then become shy, reclusiv

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

or a social phobia may develop. Acne may affect a teenager’s ability to perform well in school if a social phobia arises, leading them to refuse to be in public or in the

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

classroom.

Some teenagers develop depression through psychosocial estrangement they experience because of untreated acne. Depression is a serious mental disorder with extr

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

me repercussions and should not be taken lightly. Teenagers offering signs such as loss of appetite, mood disturbance, spontaneous crying and a general feeling of worthless

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

Professional from academic institutions, pharmaceutical industries, health care indust

ess exhibited by statements such as ‘You’d all be better off if I wasn’t here’ should be encouraged to talk with a psychologist about their troubles. Depression can lead to

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

other anxieties and unfortunately, suicide. These disorders occurred all because the acne went untreated!

Some teens experience dysmorphophobic acne, or a disturbed body

.

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

mage similar to the feeling a patient with anorexia nervosa has attained, through their acne condition. The teenager is convinced they are disgusting to look at or the mino

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

Companies that provide selfless information through particip

acne on the face is believed to be enormous and socially threatening. These patients may benefit from a low dosage of oral isotretinoin to help quell any outbreaks of acne

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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