E-Articles - Health and Fitness

Just what is GERD exactly? GERD is an abbreviation for gastroesophageal reflux dis

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

ease which is the condition a person has if they experience chronic symptoms as a

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

Examples of combination products may in

esult of reflux of stomach acid into the oesophagus.

By chronic, we mean symptoms

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

on a regular (often daily) basis, not the odd bout of indigestion a few times a ye

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

r but symptoms that affect the sufferer to the extent that it is a major part of t

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

Combination pro

eir life.

Reflux of acid and other contents of the stomach into the oesophagus is

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

not normal behaviour. Under normal circumstances, acid should be held back by a va

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

lve known as the lower esophageal sphincter.

What Is GERD Like?

This is best des

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

ribed as a painful burning sensation in the chest, sometimes spreading to the thro

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

t, that normally lasts less than five seconds, hence the name "heartburn", althoug

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

this phrase is often used to indicate a lesser condition than GERD of just occasi

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

Following aspects would a

nal symptoms.

What Is GERD Appropriate Treatment?

Appropriate treatment for GERD

dd to the challenges in developing combination products:

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

is usually not the likes of antacids. These should only be used for occasional hea

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

tburn symptoms. Most GERD sufferers take PPIs, or proton pump inhibitors. These ar

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

e highly efficient and cut acid production often by 99%. They are mostly free of s

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

vere side effects with long term use but some elderly people report a higher incid

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

Professional from academic institutions, pharmaceutical industries, health care indust

nce of hip breakages.

Some, usually to avoid the inconvenience of daily or regula

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

medication, will opt for surgery which is typically minimally invasive and does n

.

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

t require an overnight stay. However, the success rate and results of surgery vari

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

Companies that provide selfless information through particip

s and some people may still need to take medication to control their GERD symptoms

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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