Advice Pool - Health and Fitness

When we build a fire, there is an ash left behind by the burned fuel. The sa

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

me is true of our body when it burns food for fuel. The food leaves an ash.

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

Examples of combination products may in

That ash will either be alkaline or acidic, depending on the food.

Acidity

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

and alkalinity are measured on what is called the pH scale. How acidic a fo

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

d is on our plates is often the opposite of how acidic the ash residue will

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

Combination pro

be. For example, acidic fruits and vegetables tend to leave an alkaline ash

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

, while alkaline meats and cheeses tend to be acid-forming in the body. Our

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

bodies also produce acid as a by-product of normal metabolism. Because our b

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

dies are designed to be alkaline, this acid must be buffered with alkaline s

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

ubstances. However, our bodies cannot manufacture acid buffers. Food and sup

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

plementation are the only means of replenishing alkalinity in the body.

Due

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

Following aspects would a

to the Standard American Diet (SAD), most people suffer from an unbalanced

dd to the challenges in developing combination products:

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

H that is too acidic. In other words, their bodies are full of acid waste. B

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

ecause the body was meant to be alkaline, this condition forces the body to

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

borrow minerals, like calcium, from the body’s organs, ligaments, muscles, a

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

nd bones to neutralize the acid in an attempt to safely remove it from the b

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

Professional from academic institutions, pharmaceutical industries, health care indust

dy.

Because calcium is being drawn from the bones to buffer acid, this wast

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

e product causes osteoporosis. Dr. Susan Brown of the Osteoporosis Education

.

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

Project considers acid waste a major hidden cause of osteoporosis. A chang

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

Companies that provide selfless information through particip

e in diet, not just calcium supplementation, is needed to fight osteoporosis

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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