Suggest - Health and Fitness

September 13, 1999

Do you remember where you were six years ago today?

I do. It was the day I underwent gastric bypass surgery – a day tha

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

t changed my life forever.

I don’t recall much about that day. I remember feeling embarrassed lying on the preparation table, my enormous be

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

Examples of combination products may in

ly exposed to be cleansed antiseptically. I remember feeling frightened, but calm with a total acceptance that gastric bypass surgery was the

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

best decision for me. I remember the anesthesiologist, a beautiful woman, not very old and not very big.

Then I went to sleep.

I woke up p

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

king violently, an unpleasant reaction to anesthesia. I didn’t have my glasses so things were blurry, particularly the flowers from my husban

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

Combination pro

. And I can remember a push-button device that helped me sleep. Later that night I realized I was not yet smaller. In fact my stomach was blo

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

ated and sore. In my drug induced vagueness I became convinced the surgeon had mistakenly done the wrong operation because I was getting bigg

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

r, not smaller.

The day after surgery my surgeon visited me, taught me to drink tiny sips of water, patted my hand and told me I was going t

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

o do just fine. I remember walking around the hospital hallway. I remember a female nurse bathing me. I remember a very good-looking male n

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

rse – he didn’t bathe me. Rats! I remember drinking some nasty liquid chalk and getting an x-ray to confirm my stomach had been whacked, stap

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

ed and bypassed. I remember the super-sized wheel chair and being embarrassed that it fit just fine.

I remember being discharged from the ho

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

Following aspects would a

spital to spend the next several days in a hotel room because we had traveled a great distance for my “last resort” surgery. I watched “Mame”

dd to the challenges in developing combination products:

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

on TBS several times. The sofa at the hotel was scratchy. My husband and I went on “outings” each day, little drives around a strange town. H

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

e emptied my surgical drain for me. I thought it was disgusting.

One week after surgery we went to Sea World where I wept in profound disbel

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

ef at the great whales circling the pool and performing flawlessly for a bite of fish. Being from out-of-town, we sat in the “Splash Zone”. 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

rns out those warnings are for a reason. The great swimming mammal whacked his tail and we were drenched!

On Thursday of the second week Les

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

Professional from academic institutions, pharmaceutical industries, health care indust

lie, the darling nurse and counselor herself a WLS patient, removed my drain. We could go home. She asked me the four rules and I repeated t

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

em to her. She told me, “Take advantage of this window of opportunity. Learn everything you can. If you don’t learn early to follow the rules

.

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

and take care of yourself you can regain this weight.”

Starry eyed and hopeful we packed ourselves in the car and headed for home. Almost 1

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

Companies that provide selfless information through particip

500 miles later we pulled into the driveway of home sweet home. My fabulous husband said to me, “Welcome to your new life – You Have Arrived.

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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