Advice Pool - Health and Fitness

You may have heard of a supposed relationship between sleep apnea and GERD. Scientist

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

s, even today, are still baffled by this mystery. According to statistical tests, the

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

Examples of combination products may in

re is a significant correlation between the two. When someone has GERD, there is a hi

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

her than average chance that they also have sleep apnea, and vice versa.

But does th

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

is mean that one is causing the other? There are two hypotheses.

One is that suffere

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

Combination pro

s of sleep apnea have to breathe harder during sleep and this induces the reflux acti

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

on of GERD.

The other theory is that GERD sufferers may experience vocal chord spasm

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

due to the reflux action, which can cause sleep apnea.

The just is still out on thi

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

s apparent relationship between sleep apnea and GERD. Although they seem to be linked

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

or occur together, it has also been seen that they tend to appear at different times.

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

Remember, just because you see two conditions in the same people regularly, it does

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

Following aspects would a

not mean that one is causing the other. For instance, excess weight or being obese c

dd to the challenges in developing combination products:

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

n increase the chances of both so this is one example of a common risk factor for bot

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

h sleep apnea and GERD.

One benefit of the identification of this correlation betwee

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

sleep apnea and GERD is that we may be able to diagnose illnesses that had previousl

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

y gone unnoticed.

For instance, GERD may not always produce symptoms, even though da

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

Professional from academic institutions, pharmaceutical industries, health care indust

age may be being done to the oesophagus. If we set up a screening program to look for

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

evidence of GERD in sleep apnea patients, we may be able to help many people whose c

.

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

ndition would otherwise have remained dormant and undiagnosed. They can then be put o

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

Companies that provide selfless information through particip

n an appropriate course of treatment for both conditions, sleep apnea and GERD

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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