E-Articles - Health and Fitness

My husband and I went on the atkins diet several years ago. This is the first time my husband ha

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

s done any dieting. I on the other hand have tried every diet know to mankind. Of course he dropped 10 pounds the

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

Examples of combination products may in

first week, and could not understand why I am always saying that weight loss is difficult. I did lose 6 pounds

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

he first week so I had to agree that the diet was working.

The first two weeks were difficult to get used to eat

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

ing only low carbohydrate foods. Once we got past that two week mark we found that it was an easy diet for us to

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

Combination pro

follow. On the atkins diet you eat mostly protein. My husband has always been a big meat eater so that

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

part was easy. It was more difficult for him to give up the potatoes and bread that he ate along with his meat.

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

We needed to find alternative foods that were allowed on the atkins diet.

I bought the atkins diet book which

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

not only outlines the diet but also has recipes. It is amazing how you can eat a lot of food on the atkins diet

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

and still lose weight. The main challenge is getting some variety into your meals. When we first started the at

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

kins diet the dinner meal was very easy to prepare. We would have some type of protein, fish, animal protein, ch

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

Following aspects would a

icken or beef and a large leafy salad with bleu cheese dressing. This was not that different than what we ate be

dd to the challenges in developing combination products:

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

ore it was just minus the potato and bread.

After a few weeks the lack of variety started to bore us. We were b

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

oth losing weight, so that helped keep us motivated, but we were getting tired of the same meal each night. Then

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

I discovered some of the recipes in the back of the atkins diet book. Our favorite is mashed cauliflower. It is

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

the same texture as mashed potatoes. The atkins diet book also had a recipe for a salad that has all the same i

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

Professional from academic institutions, pharmaceutical industries, health care indust

gredients as potato salad, minus the potatoes. You substitute cooked cauliflower. I was doubtful at first, but

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

it tastes wonderful.

Over the years we have added carbohydrates back into out diet. Initially we both gained so

.

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

e of the weight back, but now we have found the right balance for each of us. Long term with very low carbohydra

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

Companies that provide selfless information through particip

tes did not fit our life style, or taste buds, but the atkins diet was an effective way for us to take off pounds

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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