Advice You - Business

All of us are busy working in a particular area to earn our living. Som

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

e of us are business persons and some are employed. Some are engineers,

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

Examples of combination products may in

others doctors, carpenters and so on. We have painters, architects, fir

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

emen and all types of professionals.

The question is - Why did you cho

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

se a particular profession? Were you tested scientifically in our child

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

Combination pro

ood about your aptitude, or whether it was your family profession, or y

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

ou wanted to become one because you had fancy for that, or you had noth

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

ng else to chose so you chose your current profession?

Along the way i

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

n life, we stop asking these questions and continue doing what we are d

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

ing. We never think about why we are doing a particular kind of job. We

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

never look around for total change in the job. For example - an enginee

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

Following aspects would a

r would very rarely think about dropping out of his/her profession and

dd to the challenges in developing combination products:

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

ecoming a full time musician. Why?

Why most of us don't think about ch

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

anging our profession altogether? Why don't we think in that direction

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

t all? One reason is to maintain status quo, which gives us comfort. We

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

want to live in our comfort zone. The second reason is that we never qu

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

Professional from academic institutions, pharmaceutical industries, health care indust

estion ourselves- Am I in a profession that I like fully? Can I choose

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

nother profession that will give me more success and joy?

Please think

.

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

about what I have said and rethink about your profession. You may find

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

Companies that provide selfless information through particip

something else that may give you not only satisfaction but great succes

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 You - Are You In The Right Profession?

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