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The Atkins Nutritional approach has been used nationally since the 1960’s. Long before Dr. Robert Atkins published his popular low-carbohydrat

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

e diet plan, his patients were reaping the benefits of the Atkins diet.

Dr. Atkins divided his meal plan into four phases. “Induction,” phase

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

Examples of combination products may in

one, is designed to force the body into ketosis, a physical condition which occurs in response to starvation. The “ketogenic” diet is widely

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

sed in medicine not only to treat obesity, but also to treat conditions such as epilepsy and diabetes. During this particular two-week period,

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

no alcohol or caffeine can be consumed.

The second phase, “Ongoing Weight Loss,” is geared toward finding the “Critical Carbohydrate Level f

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

Combination pro

r Losing.” This process involves increasing the carb intake by five grams per week until the subject a person is within 10 pounds of their tar

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

get weight.

“Pre-maintenance” is the next step. Like phase two, this phase calls for an increase in carb intake, the difference between the t

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

wo phases being that this phase is designed to find the “Critical Carbohydrate Level for Maintenance.”

Step four is “Lifetime Maintenance,” a

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

phase intended to reinforce the habits learned through the diet plan so as not to regain the weight lost during the diet. Dr. Atkins also emph

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

asizes making use of the option to jump back to any of the other phases if weight begins to return.

While many testimonials of success have b

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

en recorded, the Atkins diet has been under fire in recent years as more and more analysis is conducted. Recent studies have compared Atkins t

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

Following aspects would a

o other diet plans and found that it scores among the highest for short-term weight loss but ranks as the lowest for long-term weight loss. 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 after Atkins Nutritionals released their line of Atkins diet bars and meals, Forbes Magazine analyzed several diets and found that the avera

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

e consumer would pay up to 80% more in food costs than people not on the diet. Even when faced with these facts, many still sing praises of th

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

e Atkins diet.

Both the New England Journal of Medicine and the American Journal of Medicine confirmed that Atkins is still the most effectiv

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

published diet plan for short-term weight loss. They do, however, acknowledge that it does come at greater risk for coronary heart disease. A

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

Professional from academic institutions, pharmaceutical industries, health care indust

s for weighing out the pros and cons to determine exactly how much more at risk those who participate in the Atkins diet are, all reports foun

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

d that no evidence documented has yet to prove that the risks are greater than the benefits.

Nearly forty years later, the late Dr. Atkins is

.

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

still recognized for his approach to weight loss. Thanks to the innovation of the internet, Atkins meal plans, Atkins diet bars, Atkins recipe

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

Companies that provide selfless information through particip

s, magazine articles and research regarding Atkins and virtually anything else associated with the Atkins diet has never been easier to access

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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