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The holiday season between Thanksgiving and New Years every year co

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

mes with much eating during festive celebrations. So it makes sense

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

Examples of combination products may in

that people are forewarned in advance to take everything in modera

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

tion. That is not always possible during family visits as you do no

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

t wish to upset your relatives by refusing their gracious food offe

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

Combination pro

rings.

Additionally it is not easy to find time to workout, walk,

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

jog or run during holiday visits at family’s homes. This indeed aff

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

ects your ability to stay fit. This double whammy is what causes th

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

e additional pounds to accumulate. There are ways to stay fit and t

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

rim during the holiday season. How so you ask?

Well one way is to

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

watch the foods, which add weight and fat. If you are not going to

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

Following aspects would a

use the food for your body to burn off to work out then you should

dd to the challenges in developing combination products:

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

not be eating it, as it serves no purpose. Of course it is best if

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

you find ways during the holidays to work out a little. Even if you

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

can take a walk for 30-40 minutes with a family member this can he

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

lp. You can even volunteer to walk the dog as well.

That is an exc

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

Professional from academic institutions, pharmaceutical industries, health care indust

ellent excuse to get out of the house and move your muscles. Maybe

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

you can help and overweight family member get started early on thei

.

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

r New Year’s Resolution by taking them with you. Do not be Afraid o

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

Companies that provide selfless information through particip

f Over Eating During the Holiday Season, take action. Think on this

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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