E-Articles - Health and Fitness

It was the same thing since I was 15. Wake up in the morning, look in the mirror hoping for clear skin, only to find several more d

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

isgusting blemishes all over my face that I would have to spend all morning trying to cover before leaving the house.

I tried ever

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

Examples of combination products may in

thing from soaps and lotions to prescription medication from my doctor. Some helped, some made the problem worse, and I started to

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

notice that my skin, whether it cleared or not, got extremely sensitive and would turn red at the drop of a hat. If I got emotional

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 face was flushed. Too hot, too cold, same thing. I looked like I was embarrassed ALL the time. And it's embarrassing to look em

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

Combination pro

arrassed when nothing is bothering you.

It wasn't until I was in my late twenties that I finally had a doctor who took me seriousl

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

y. Mortified that I was still breaking out despite everything I'd tried, I asked my doctor for something new to give me clear skin.

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

He looked closely, then again, and said, "That's not acne, you have rosacea".

Finally! A proper diagnosis. Turns out everything

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

'd been using on my face was fine when I was a teenager, but was not suitable for the real problem I had now. Rosacea.

Rosacea can

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

look like acne, with the redness, bumps, pimples and pustules, (which is why it is often called adult acne) but there is a huge di

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

ference. Rosacea is actually a disorder of the blood vessels in the face and involves inflammation, and can also affect the eyes.

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

Following aspects would a

f untreated, the facial flushing can occur more often and persists for longer periods of time, until finally the tiny blood vessels

dd to the challenges in developing combination products:

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

become visible permanently. The most severe cases can be disfiguring.

My doctor said that many things can trigger flushing, incl

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

ding excessive heat, spicy foods, hot beverages, alcohol, caffeine, humidity, and being too harsh with my skin. He suggested a gent

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

e cleanser (I really like Spectrogel now) and prescribed a topical antibiotic gel which is specially formulated for the treatment 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

f rosacea.

What a difference! I no longer use cleansers or pimple creams meant for teenagers, ever, and I am never without a back

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

Professional from academic institutions, pharmaceutical industries, health care indust

p tube of my prescription. I still blush when someone embarrasses me, but I don't have the facial flush that sneaks up on me for no

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

reason and refuses to fade. I wear a lot less makeup, and I hardly have to spend any time covering up blemishes.

Don't be embarras

.

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

sed. If your doctor dismisses your skin condition as a problem from your teenage years that you have to put up with, ask questions.

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

Companies that provide selfless information through particip

It is worth it to finally get to the root of the problem, and when you start treating it correctly, you'll be amazed at the results

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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