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One of the forerunners of the sudden boom in the diet industry is the South Beach Diet. Since its birth as diet program for the people w

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

ith heart problems in a small clinic in South Beach (you guessed it!), the diet has gained a lot of following across the country.

Where

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

Examples of combination products may in

it all started

The South beach diet program was created by Dr. Arthut Agatston, a cardiologist, for his patients. Despite the percepti

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

n, South Beach diet is not a low carbohydrate diet. Instead, it is based on the Glycemic Index, a scale where in people can find the eff

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

ects of various carbohydrate-rich food on their blood sugar level. South Beach diet focuses on finding a balance on the foods that bring

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

Combination pro

in the good carbohydrate and fats and the foods that don’t.

Phases to go through

South Beach diet involves different phases that diete

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

rs must take in order to complete the program. The first phase is the most crucial and the strictest part as it involves a major change

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

in the eating lifestyle of the person. In this phase, the person on a diet is forbidden to eat anything but fish, shellfish, meat, chick

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

n, turkey, vegetables, nuts, eggs and cheese. They are not allowed to take in carbohydrate-rich food such as bread, rice, pasta and cere

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

als. Ditto with sugar-rich food such as candies, ice cream, cakes, and even fruits. This phase will last for a period of two weeks.

Wha

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

is different from other diets is the fact that people under the program are allowed to each as much as they want. There is no restricti

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

Following aspects would a

on when it comes to the quantity. In fact, they are even allowed to take three meals a day plus an added boon, the additional morning an

dd to the challenges in developing combination products:

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

d afternoon snacks and the dessert. Of course, they are advised to drink lots of water, coffee and tea.

The second phase in the program

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

involves an unspecific period of time as it depends solely on the progress of the diet. It will run until the person reaches his or her

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

ideal weight. In this phase, the dieter will have to incorporate the carbohydrates back into the daily diet but only in moderation. This

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

takes patience as dieters can only lose about two pounds a week, which can be really frustrating as they have lost as much as 13 pounds

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

Professional from academic institutions, pharmaceutical industries, health care indust

in the previous phase.

After reaching the ideal body weight, dieters will go through the third phase, which is actually the maintenance

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

of the new eating lifestyle. Creators of the South Beach diet hopes that through the program, the body has changed the way it craves fo

.

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

food.

For instance, because the body has not taken in much carbohydrates; it will cease to crave foods that are rich in carbo. The aim

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

Companies that provide selfless information through particip

of the third phase is actually quite simple. Dieters need only to maintain the ideal weight that they have achieved in the second phase

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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