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Did you ever get a feeling or gain notion of a specific situation without any logical explanation? Well, that is your int

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

uition. When you least expect it intuition reaches out and hits you with information that you have no idea were it came f

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

Examples of combination products may in

om. The problem with this type of feeling or knowledge is that we have no logical explanation for it and often do not fol

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

ow what it’s trying to tell us. However, many find that when their intuition is over looked, it later proves itself to be

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

a fact and regret not following it. Well, I will tell you about what happened to me when I ignored my intuition.

When I

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

Combination pro

gave birth to my second daughter I had just moved to another state. Therefore, I did not have a pediatrician for my daugh

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

ers. But, my Doctor and a nurse both recommended one and I followed their advice.

When I took my newborn several days la

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

ter for a check up there was something wrong. I had a bad feeling about this man and every time I met with him the negati

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

e “gut feeling” would come back. I even discussed it with my husband and he suggested we change the Doctor. I told him th

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

t there was no rational explanation in order for me to change him.

Within several more visits my “gut feeling” disappeare

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

. After a while I learned to appreciate him and though he was a great doctor.

Until, the day that I was watching the fiv

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

Following aspects would a

e o’clock news; the news lady said a local doctor pleaded guilty to child molestation charges; and guess what? You know i

dd to the challenges in developing combination products:

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

, his picture was on the news and now I just stood alone frozen in my living room unable to pick my jaw back up. Once I r

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

covered from the state of shock; I was thankful that my girls were never left alone with him. Not even for a second. But,

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

I could not help but, think that my intuition was right and that I did not listen to it. I felt as if it crept back up o

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

me and was now saying: I told you so!

Now, I understand that even if some feelings, thoughts etc, cannot be rationalize

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

Professional from academic institutions, pharmaceutical industries, health care indust

here may be a reason for it and even If I decide to do the opposite; I will be sure to pave the way with caution.

I sugge

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

st that you don’t wait for a life turning event to listen to your intuition I was lucky it was not one of my daughters. Bu

.

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

, I do regret placing them next to some one that my inner self did not approve of.

Intuition is there to help you,

Kenia

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

Companies that provide selfless information through particip

Morales

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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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