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It may not be politically correct to tell you that a woman should make herself beaut

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

iful, sexy, and feminine. However, if you don’t, then that nice, sweet, but unbeauti

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

Examples of combination products may in

ful, un-sexy, and unfeminine woman may spend many lonely, unhappy years being politi

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

cally correct and unnoticed by most men.

I was terrible at finding a man who was go

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

od for me. Again and again I would chase after men. From the age of 20 until in hit

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

Combination pro

35, I had a bit of a feminist attitude. I was not shy and quiet. I approached men, i

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

nitiated contact, and pursued them. But twenty of them-every one--- ran from me, avo

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

ided me, showed no interest in me.

It was 1986. I carried too many extra pounds on

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

my 4-foot-9-inch frame. I paid little attention to my make-up, my hair or my clothes

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

. One day at the city college library I saw a student I liked. We had often passed e

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

ach other on campus, and said, “Hi.” On that rainy day, I walked over to him in the

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

Following aspects would a

library and asked him if he could give me a ride home. He said to me, almost angrily

dd to the challenges in developing combination products:

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

, “Are you insane? Why do you think that I am interested in you? You don’t act like

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

a woman. Why would I care to talk to you?” I was shocked. In that moment I was a tot

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

al loser. I was insulted and hurt. What else could be a worse way to hurt a woman th

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

an to say, essentially, “You are not a woman”? But that was the truth in men’s eyes:

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

Professional from academic institutions, pharmaceutical industries, health care indust

I was not seen a woman, not noticed as a woman. My niceness didn’t impress the men.

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

Inside, I knew I was a nice woman, but my outside appearance made men not even thin

.

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

k of me as a woman. I was not a woman to men because I wasn’t dressing and acting li

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

Companies that provide selfless information through particip

ke a woman and I was heavy and unattractive, not pretty, not sexy, and not feminine.

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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