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I had what you would call a religious up bringing. We were taught the 10 commandments at a very early age. In fact the 10 command

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

ments have played such a large role in my life I cannot remember when I learned them. I remember having to memorize them for Sunday schoo

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

Examples of combination products may in

l, but that was more trying to remember what order the 10 commandments came in rather than learning what they were.

Because the 10 comman

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

dments have been a part of my life since I was a little child, I have not spent much time reflecting on them. As with so many aspects of

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

my faith I have just accepted the 10 commandments as a fact of life. I have spent more time pondering them recently due to the media atte

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

Combination pro

ntion of having the 10 commandments displayed in public buildings. I had to stop and review exactly what the 10 commandments are and why

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

someone may be offended seeing them in print. I had to stop and reflect if I had just accepted something that may be offensive just becau

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

se it has always been part of my life.

I have to admit that trying to recall the 10 commandments in order was a true memory exerci

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

se. I could remember all of them but trying to get the middle ones in the right order was a challenge. I mentioned this to my husband an

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

d he could not understand why being in a particular order made any difference. I thought he had a good point, that it did not really matt

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

er what order I placed them in or what exact wording I used to remember them, it was the idea behind each of the 10 commandments that was

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

Following aspects would a

the message we are to take to heart.

After thinking about each of the 10 commandments I have decided that for me they are not offensive.

dd to the challenges in developing combination products:

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

I would not feel discriminated against or violated in any way seeing them in print. The message with each of them is clear to me and in

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

general I feel they out line a decent and courteous way to conduct my life. I respect others beliefs and accept that not everyone has the

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

same set of beliefs that I have. In fact I think life would be boring if we did all think the same and had the same beliefs.

Although I

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

comprehend that we are not all from the same belief system, I still cannot understand why someone would be offended by seeing the 10 comm

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

Professional from academic institutions, pharmaceutical industries, health care indust

andments in print. There are many billboards and bus advertisements out there that I find disagreeable or offensive, but I know there are

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

others who have opposing opinions. If I find something offensive I try to look at something that is more appealing to me. We do not all

.

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

need to believe the same things and in order to co-exist , we do not even need to understand each others beliefs, we just need to learn t

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

Companies that provide selfless information through particip

olerance. Hey, maybe I just came up with the 11th commandment! In fact, it can be any number. I've already told you order doesn't matter.

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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Sounds obvious, but many problem-solving projects fall apart at what should be the easy part. Choose a solution strategy that works, i.e., fixes the right problem and is practical for your situation. Then implement the strategy--completely. The problem won't go away if you get distracted by other projects and never finish. This article includes ideas to help make sure you get to really do solve that problem.

He popped the question; and you said yes. Now you want to find the perfect invitation to set the theme of your wedding.

Antioxidants have been making headlines all over the world in regards to their healing and skin-protecting qualities. But as research continues, new antioxidant discoveries are being made every day. Below is a brief overview of some of these new, exciting ingredients and how they can benefit skin and the body.

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