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One of my favorite Thanksgiving dinners when I was growing up wasn’t even turkey; it was pizza. We were supposed to go to my aunt’s house for dinner, but my sis

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

ter and I woke with colds, so we couldn’t go. This was before grocery stores were open 24 hours, so my mother had to feed us the only food we had in the house:

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

Examples of combination products may in

frozen pizza. She was upset, but for my sister and I, there was something gloriously naughty about not having turkey for Thanksgiving. Between coughing and sn

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

eezing, we enjoyed our rebellious pizza and couldn’t wait to tell our friends about it.

At another Thanksgiving, I walked into the kitchen to help my mother ser

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 the turkey and we both saw the possible disaster at the same time: the cat on the kitchen counter next to the turkey. I will never forget the sight of my moth

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

Combination pro

r’s horrified face as we listened to the guests in the next room blissfully unaware of the turkeyless possibilities. There was a long pause as she weighed her o

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

ptions. My mother swore me to secrecy and we served the turkey. She never told anyone else why she threw half of it away. She told me that was just a precauti

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, because as she slowly explained, she didn’t really think the cat had actually touched the turkey but she didn’t want anyone to eat something that had cat brea

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

th on it. (Uh oh, you won’t tell my relatives will you? I’ll have to tell everyone that’s ever eaten at my house that they can’t read this article.)

Another f

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

vorite Thanksgiving of mine was the first one that my husband cooked when we were newlyweds. My husband had proudly decided that he would cook the turkey. He w

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

s excited about doing it until he realized that in order for us to eat at lunch time he would have to get up at 5:30 AM to put the turkey in. And he didn’t real

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

Following aspects would a

ize that he’d have to put his hand into the turkey to get the giblets out. I didn’t realize he was so squeamish. He complained so loudly the next morning that

dd to the challenges in developing combination products:

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

wordlessly crawled out of bed, ripped the giblets out of the turkey, and with a disgusted look, I dared him to wake me up again.

That was also the Thanksgiving

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

that we learned our most important lesson about using a food processor – never, never try to make mashed potatoes in one. The lady on the other end of the food

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

processor hotline that we frantically dialed was very kind and sympathetic. I bet she’d been getting those calls all day. Unfortunately, food processors take t

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

e air out of mashed potatoes. Imagine the opposite of light, fluffy potatoes- that’s what we had. It was like mashed potato glue. Thank goodness for a box of

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

Professional from academic institutions, pharmaceutical industries, health care indust

instant mashed potatoes.

Men’s need to carve turkeys always amuses me. Did you ever notice that men can lounge all day in front of the television doing nothin

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

to help with dinner, but they spring to action when the turkey is set on the table. Suddenly the women who have been cutting, chopping and peeling for hours (s

.

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

ometimes days) can’t be trusted to hold sharp objects. Only men can carve the sacred bird.

Every year on Thanksgiving, I consider cooking something different:

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

Companies that provide selfless information through particip

aybe ham or roastbeef, but I can’t quite bring myself to change the tradition. But I always make sure to have a frozen pizza just in case. Happy Thanksgiving

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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