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Our world seems confused right now! Should we move forward or stay right where

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

we are? Who knows the answers?

Confusion is an opportunity to stop and refocus.

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

Examples of combination products may in

It is a warning signal our mind sends us saying "HELP! Do something different!"

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

So what does our brain want and how can we refocus?

Here are 7 steps to assist

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

this process.

1. STOP The definition of insanity of doing the same thing ove

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

Combination pro

and over and expecting different results. So STOP the insanity!

2. WRITE Put

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

all the scrambled thoughts onto paper. Would you rather be swept up in the chur

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

n of the tornado or safely watch the event from the next town? By writing your

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

houghts, you remove yourself from the "churn" and can look at the confusion from

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

a safe distance.

3. IDENTIFY Now you can safely look at your thoughts and beg

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

n to identify categories that are creating the confusion. Often it is not as un

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

Following aspects would a

daunting a list as we think it is when we stop the "churn".

4. RATE Take each

dd to the challenges in developing combination products:

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

area and rate it based on your ability to impact the outcome. In other words, b

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

taking action are you in charge of creating the results you desire or does some

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

one else hold the power? You will find that some areas are in your control and

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

ome are not.

5. CHOOSE Choose an area you can control and then develop a plan

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

Professional from academic institutions, pharmaceutical industries, health care indust

of action.

6. DO Implement your plan. By taking steps in one area you may fi

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

nd that results happen in other areas. It is almost magical!

7. EVALUATE Onc

.

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

you are on your way, you can go back and chose another area OR recognize the su

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

Companies that provide selfless information through particip

cess you achieved and what you have learned to make the process better next time

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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