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I know eyebrows are probably raising about now, but let me tell y

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

ou this works ! How does God know what we want or need if we don'

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

Examples of combination products may in

t get specific and let Him know ?

All you have to do and I do th

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

s on a monthly basis and update it accordingly is make a list. I

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

make mine like a grocery list and put the title at the top of the

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

Combination pro

list. My title is always "OK God ... This is what I need now !

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

and proceed to make the list. I make the list and leave the how t

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

his will manifest to God. That's His department.

An example of h

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

ow mine might read for the month:

Rent ... fill in the exact amo

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

nt

Electric ... fill in the exact amount

I list all my debts ow

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

ing with the amounts when I know them. Things like groceries, gas

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

Following aspects would a

, etc... that I don't quite know what the amount might be I still

dd to the challenges in developing combination products:

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

add.

I also add other things besides financial. I might need a b

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

usiness contact to help promote my services or information about

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

something. I add it to the list.

Whatever I need I add to the li

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

t and keep it right beside my computer so it is within reach when

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

Professional from academic institutions, pharmaceutical industries, health care indust

I want to add additions. I check off each item as it is fulfille

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

d and always, always say a big Thank You ! . Being grateful is an

.

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

important part of this.

Leave the details to God on how this l

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

Companies that provide selfless information through particip

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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One woman prompts the reader to consider living life never having to make decisions. EVER!

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