Advice Pool - Self Improvement

Life is an enigma...It starts without our knowledge, grows witho

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

ut our suggestions and ends without our consent. Life is not abo

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

Examples of combination products may in

ut 'either-or', its all about 'this-and-that.'

This is a space

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

here joy and sorrow walk hand in hand, this is a space where tri

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

umph and disaster are two sides of the same coin, this is a spac

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

Combination pro

where all and none exists!!!!! It is on us.... what we wish to

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

see and what we choose to ignore.

Failure brings with it the jo

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

ys of learning, the knowledge to appreciate that its human to er

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

and the wisdom to accept that certain things are beyond our con

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

trol.

Life is beautiful with all its colours, some bright some

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

ull some in stark contrast while some in shades. Its the amalgam

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

Following aspects would a

ation of all that makes it so rich. The light wouldnt be welcome

dd to the challenges in developing combination products:

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

if there was no darkness, success wouldnt be celebrated if ther

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

were no fear of failure, a smile wouldnt be appreciated if ther

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

e were no tears.

The good and the bad, the beautiful and the ug

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

y, the right and the wrong- they are all within us. its all abou

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

Professional from academic institutions, pharmaceutical industries, health care indust

t what we choose and when??

Happines is a choice and not a chan

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

ce. Afterall, life is 15% of what happens to us and 85% of how w

.

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

react to it. As Henry Ford said, "If you think you can or you c

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

Companies that provide selfless information through particip

an't, you are always right."

So today, lets make a choice......

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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Advice Pool - What Do We Choose?

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