E-Articles - Health and Fitness

I wa

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

nt to get close

I am afraid.

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

Examples of combination products may in

fraid of what you might see.

M

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

y eyes.

My thoughts.

My dream

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

.

My heart.

My soul.

Everyth

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

Combination pro

ing that makes me who I am.

My

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

feelings.

My emotions.

The tr

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

uth of my own reality.

The rea

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

ity that I am scared.

Every se

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

cond.

Every minute.

Every hou

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

.

Every day.

Scared of not be

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

Following aspects would a

ing perfect.

Scared of looking

dd to the challenges in developing combination products:

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

stupid.

Scared of being in the

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

way.

Scared of getting comfor

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

able.

Getting comfortable mean

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

s stability,

Stability means f

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

Professional from academic institutions, pharmaceutical industries, health care indust

rever.

I dread forever.

So, I

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

am ready,

to move on,

to con

.

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

inue my journey,

To continue m

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

Companies that provide selfless information through particip

y life....

I AM READY!

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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