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Keeping a positive attitude is not always easy, especially when it seems that no on

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 else around you has a positive attitude. It seems like people are always complain

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

Examples of combination products may in

ng about something. They have bad attitudes towards their jobs, boss, life, spouse,

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

relationships, economy, government, kids, and even the weather.

How in the world a

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

e you supposed to keep a positive attitude when all of this negative stuff is going

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

Combination pro

on around you?

One of the keys to keeping a positive attitude is to always remembe

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

your ‘WHY’. Why did you start doing what you are doing in the first place, i.e. yo

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

r job, marriage, or business? If the reason you are doing these things is strong en

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

ugh, then you will be able to stay positive because you know what you want your end

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

result to be.

However, if you don’t know why you are doing what you are doing, the

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

it’s going to be very difficult to stay positive. Maybe you started something but

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

Following aspects would a

ou no longer have a desire or passion for it. What do you do then?

The first thing

dd to the challenges in developing combination products:

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

to ask yourself is, have you truly lost your passion for what you started, or are y

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

u just in a slump or in a down time. You will certainly go through down times, but

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

f your ultimate goal is still there you can work through them.

However, sometimes

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

hings change and you no longer have a desire or passion to continue with what you h

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

Professional from academic institutions, pharmaceutical industries, health care indust

ve been doing in life. It’s at these times that you need to re-evaluate what your l

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

fe’s dreams are. Remember, you only have this one life to live, so what’s the point

.

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

of living it doing things that you hate.

You will be amazed how negative attitudes

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

Companies that provide selfless information through particip

will change into positive attitudes if you have a clear focus on your ‘WHY’ in life

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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