Advice Pool - Health and Fitness

Anorexia Nervosa is probably more common in today's 'media' focused era more tha

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

n it ever has been before. Anorexia Nervosa is a very complex eating disorder/di

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

Examples of combination products may in

ease that involves both psychological and sociological components which result i

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

the voluntary starvation and exercise stress by an individual.

Anorexia Ner

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

osa: "A psychophysiological disorder usually occurring in young women that i

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

Combination pro

characterized by an abnormal fear of becoming obese, a distorted self-image, 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

ersistent unwillingness to eat, and severe weight loss. It is often accompanied

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

y self-induced vomiting, excessive exercise, malnutrition, amenorrhea, and other

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

physiological changes."

Our daily definition of this condition often overlooks

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

he actual psychological part of the condition which is often times the greatest

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

actor. Medical professionals are still not able to completely characterize the c

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

Following aspects would a

uses of anorexia, and as such are the subject of debate in several instances. G

dd to the challenges in developing combination products:

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

nerally we have been able to agree that it is both physiological and psychologic

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

l.

If we look around at the media and the pressure that is placed on women to c

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

nform to a certain image, it's easy to understand why anorexia is a growing prob

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

em in our society. Paula Abdul, Courtney Cox, Elton John, Calista Flockhart, Mar

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

Professional from academic institutions, pharmaceutical industries, health care indust

e Osmond, Elvis Presley and Mary-Kate Olsen are a few on the growing list of cel

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

brities themselves that have suffered at one point from an eating disorder. Self

.

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

Confidence is a crucial element in developing this aspect, and as individuals is

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

Companies that provide selfless information through particip

something that we should always strive for, before trying to be "peer-confident.

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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