Your Space - Health and Fitness

Do you wake up in the middle of the night gasping for breath? Do you wake up numerous times durin

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

g the night? Do you feel like you are a walking person asleep? Is it hard to concentrate? Do you

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

Examples of combination products may in

all asleep watching television or reading a book? If you answered any of these questions with a y

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

s, read on.

About a year ago I started waking up during the night gasping for breath. This went

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

n for months before I realized what was happening. I had literally stopped breathing many times d

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

Combination pro

uring the night.

This frightened me. Many things can happen when you stop breathing:

(1) Heart

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

ttack

(2) Stroke

(3) Brain damage

(4) Death

Sleep Apnea is a scary disease to have and must b

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

addressed immediately.

Recently I had a sleep study done and it was a complete education unto i

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

self. For you people out there that are afraid to have a sleep study run on you I want you to kno

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

w it is not painful.

You go into a sleep study room and a technician attaches a bunch of electro

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

es to your head and various parts of your body. You are given a comfortable bed to sleep in and t

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

Following aspects would a

at is all that is required of you. Presto the study is complete and the results get sent to your

dd to the challenges in developing combination products:

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

octor.

This study is extremely important it will outline where your breathing problems are and h

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

ow to eliminate this stressful time from your life.

HELP IS ON THE WAY:

There is a small plasti

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

device that fits over your nose and when you sleep you wear this device. This device keeps your

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

ir ways open. You get a nice quiet undisturbed sleep during the night without waking up constantl

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

Professional from academic institutions, pharmaceutical industries, health care indust

not breathing. This device is attached to a machine and it does all the work.

I fully recommend

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

each and every one of you that have this problem to have a sleep study performed. I did and now

.

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

can leave my breathing to the professionals.

Thank you very much for reading my article. Please

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

Companies that provide selfless information through particip

feel free to read my other numerous articles on various subjects.

Copyright 2006 Linda E. Meckle

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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