E-Articles - Health and Fitness

With all kinds of drinks out there (cola, root beer, lemon-lime drinks, and many fruit juices), how could you not

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

slam down the calories. Come on, it's a hot summer day and you reach for your ice cold soda or lemonade. However

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

Examples of combination products may in

there is definitely something you need to know about these drinks. They each contain around 30-40 grams of sugars

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

per serving. At 30-40 grams of sugar per serving, that adds up to 120-160 calories. Considering that the average

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

erson consumes around three drinks daily, that adds up to 360-480 calories a day. Now you are seeing the picture.

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

Combination pro

To help make this article’s point clear, I will use an example. Let’s say that a person weighing 200 lbs needs

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

000 calories a day to maintain that weight. (This is only for an example and in no way constitutes a dietary sugg

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

stion) If this person drinks the average three drinks a day, it would compromise around 25 percent of their daily

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

caloric intake. However, we all know that this person did not take into account the calories in their drinks. Th

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

is translates into an extra 360-480 calories over what they need a day.

Well guess what? At the rate of 360-480

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

alories a day over the top of the needed calories, this person will gain roughly 3-4 lbs a month. That’s 3-4 lbs

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

Following aspects would a

month just from their sugary drinks. Can you believe that fact! However, there is a light in the end of this tun

dd to the challenges in developing combination products:

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

el. By cutting out the drinks, this person could reduce their weight by 3-4 lbs a month. Not too shabby for just

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

watching the fluids. There definitely is a lesson here and it is:

Do not drink your calories!

Now that the

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

point is clear, let’s hit real close to home. You make a pitcher of orange juice. It’s okay because orange juice

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

is good for you. However, you drink two eight ounce glasses in one sitting (which is very easy to do). You have

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

Professional from academic institutions, pharmaceutical industries, health care indust

ust now consumed 240 calories. Astounding, isn’t it.

Then how do you combat chugging your calories? It is simpl

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

e. Always opt for water or low calorie drinks when you are thirsty. There are numerous diet or sugar free drinks

.

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

out there. A word of caution though; a lot of people will find they are allergic to certain sweeteners. Always t

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

Companies that provide selfless information through particip

st a small sample before you dive into a new drink.

By the way water will always be the best choice for your body

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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