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You look into the mirror and suddenly find your face scarred by wrinkles. Is it just aging? Too much s

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

un! Or is stress the culprit? The process from which the skin wrinkles is rather complicated, but the

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

Examples of combination products may in

treatment can be simple. Botox. Treatment with Botox cosmetic can visibly smoothen your face. Botox wi

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

l soften moderate to severe frown lines & lines between your brows. An improvement can be seen within

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

days and your youthful face may last up to 4 months, although results tend to vary from individual to

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

Combination pro

individual depending on their living habits and medical profile.

It is a strange twist of medical sci

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

nce that a toxin produced by the bacterium Clostridium botulinum should get used as fountain of youth.

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

That is what Botox is - a toxin produced by Clostridium botulinum. In large, this toxin may cause par

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

alysis or botulism, a disease popularly associated with food poisoning. However, small, diluted amount

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

of Botox directly injected into specific muscles by trained medical practitioners will cause controll

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

ed weakening of the muscles and thereby help remove wrinkles from the skin.

The FDA approval for Boto

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

Following aspects would a

x first came in 1980, when it was discovered that mild amounts of Botox could help cure ailments such

dd to the challenges in developing combination products:

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

s blepharospasm (uncontrolled blinking) and strabismus (lazy eye). It was in April 2002, that Botox ga

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

ined FDA approval for treatment of moderate-to-severe frown lines between the eyebrows - called glabel

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

lar lines. But physicians have been using Botox in enhancing other areas of the face as well.

As a be

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

uty product Botox has certainly arrived. It is impossible for anyone to avoid the Botox craze. Top Hol

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

Professional from academic institutions, pharmaceutical industries, health care indust

lywood stars are rumored to have gone for it. What about you? Maybe you’re ready to take the plunge or

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

maybe you're just ready to start thinking about it. Whenever you decide to take that prick from a Bot

.

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

x needle, you would better make it sure that it is a fully qualified medical practitioner who is wield

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

Companies that provide selfless information through particip

ing the syringe. For an inaccurately applied Botox treatment has potential to do more damage than good

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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