Advice Pool - Health and Fitness

So you’ve just wolfed down that large pizza with your friends and just like the last time you begin hearing some pretty unsettling noises erupting from your stomach. Y

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

ou quickly excuse yourself and rush home where you spend the next hour or so in and out of the bathroom. What’s wrong with me you ask? Is this food poisoning, or is it

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

Examples of combination products may in

something else? It seems to occur every time I eat dairy. Could I be lactose intolerant?

The definition of lactose intolerance is the inability of the large intestine

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

to break down lactose, a type of sugar found in milk and other dairy products. It is caused by a deficiency of an enzyme called lactase, which can normally be found 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

the small intestine. The inability for the body to breakdown lactase has some very unpleasant side effects, discomfort and embarrassment to name just a few. Up until no

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

Combination pro

w, a person who suffered from the effects of lactose intolerance had one or two options; stay away from dairy altogether, which should not be considered due to the fact

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

that the body needs certain minerals, vitamins and proteins found in dairy to stay healthy or you’re forced to carry around a bottle of those chalky pills or that liqu

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

id lactase, which you have to choke down before ingesting any dairy.

So what are those symptoms you ask? Well, the most common of the symptoms are gurgling noises in y

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

our stomach followed by cramps. You may also have flatulence, which may or may not be foul smelling. You may also have a very bloated feeling and may also spend some ti

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

me on your “porcelain friend” with diarrhea, which may float and again might smell quite foul. In severe cases you may experience weight loss, malnutrition and slow gro

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

wth as your body suffers from a shortage of calcium, vitamin D, riboflavin, and protein normally found in dairy. Something to keep in mind is that every human is unique

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

Following aspects would a

and may react differently to different amounts of dairy ingested. Some sufferers are able to handle more dairy experiencing only mild side effects while others may not

dd to the challenges in developing combination products:

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

be able to ingest any at all without suffering from severe symptoms.

Something I did not realize was that Lactose intolerance is quite common and the number of people

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

who suffer from the symptoms really surprised me. Can you believe that there are somewhere in the neighbourhood of 30 to 50 million Americans suffering from lactose in

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

tolerance. You read that right 30 to 50 MILLION sufferers. There are also some specific ethnic and racial populations which seem to be more widely affected than others.

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

As many as 75 percent of all African Americans and American Indians and 90 percent of Asian Americans are lactose intolerant.

So while lactose intolerance is quite co

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

Professional from academic institutions, pharmaceutical industries, health care indust

mmon, living with lactose intolerance does not mean a life sentence in your bathroom. Sufferers of lactose intolerance through research can learn which dairy products t

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

hey can consume and which ones they cannot. Substitution and supplements may be for you while others may decide to use lactase liquid or tablets to aid in the digestion

.

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

of dairy. Others may decide they will explore alternative methods such as homeopathy or products like Lactagen, which claim to have a 38-day program designed to solve

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

Companies that provide selfless information through particip

your lactose intolerance problems once and for all. Whichever method works best for you remember that moderation and balance in any diet is the key to long term health.

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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