E-Articles - Health and Fitness

Many people who suffer from a persistent cough contribute it to chest ailments due to smoking, obesity, or a leftover cold. Yet rece

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

nt studies show that many of these people may have acid reflux/heartburn or GERD (gastroesophogal reflux disease). But how do you kn

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

Examples of combination products may in

w if you have this sort of ailment, or if it is indeed something that will fall by the wayside?

Prior to the last few years, the as

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

sumption by researchers was that coughing and asthmatic wheezing induced acid reflux. Yet recent studies clearly show that while in

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

ome small instances, coughing can cause a bout of acid reflux, it is indeed the reverse that is true. The opening up of the esophagu

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

Combination pro

s, the lower esophageal sphincter to be more precise, and the resultant stomach acids rising in the throat can and does contribute t

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

asthmatic wheezing and coughing.

One study written in Gut magazine online clearly shows that the correlation between coughing and

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

acid reflux is not coincidental. Nor is the previously held assumption regarding the reversal cause and effect true either. In this

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

tudy, researchers monitored gastrointestinal activity and coughing in order to ascertain which came first. Over half of all the resp

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

ondents either coughed or wheezed in that time frame, and the researchers measured the gastrointestinal activity at the same time as

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

the coughing or wheezing bout.

In over half of the cases, the acid reflux episode occurred prior to the coughing, leading the resea

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

Following aspects would a

rchers to conclude that previous assumptions regarding acid reflux were not true, and that the correlation between asthma and acid r

dd to the challenges in developing combination products:

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

flux were stronger than had been previously believed.

G.I. Motility online also contains a recent (2006) article that makes similar

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

claims based on the scientific research of their contributors. GERD is cited there as being the second highest in terms of causal f

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

ctors for chronic coughing demonstrating that between 40-70% of all cases of chronic coughing, GERD was the major causal factor.

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

ese findings resulted in their recommendation that those who suffer from chronic cough would benefit from seeking natural remedies f

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

Professional from academic institutions, pharmaceutical industries, health care indust

r GERD in addition to looking into other factors. Particularly, they suggest that in cases in which the reasons for the coughing are

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

not ever-present, or remain a mystery to you or your physician.

But what does that mean for us? Well, when we suffer some sort of

.

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

bnormality in our health, we generally want to fix it. That generally means that we need to get to the root of the issue. For GERD s

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

Companies that provide selfless information through particip

ufferers or those who think they may have GERD, adopting an acid reflux friendly diet may just put an end to the persistent coughing

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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