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Many smoking cessation products claim to guarantee that the client or us

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

er will gain no weight when they undertake their method. Some products e

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

Examples of combination products may in

ven claim that they will help you LOSE wight while quitting. Does this s

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

ound too good to be true.

It is.

Clients to my hypnotherapy practice o

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

ften expect me to assure them that they will not gain any weight when th

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

Combination pro

y stop smoking. This is not the case. They should fully expect to gain w

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

eight, but no more than 2-4 pounds once they become a non-smoker.

It is

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

a fact that smoking causes your cells to dehydrate. If you don’t believ

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

e me, take a look at the skin quality of a 40-year smoker compared to a

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

non-smoker. When you become a non-smoker your body is going to naturally

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

re-hydrate those cells. This is not fat. This is not even “water retenti

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

Following aspects would a

on” It is simply going to be water that your cells really need.

Most pe

dd to the challenges in developing combination products:

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

ople would rather be 2-4 pounds heavier and a non-smoker, than 2-4 pound

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

s lighter and a smoker.

Some people worry that they are going to crave

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

sweets or other “bad” foods once they stop smoking. Good hypnotherapy c

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

mpletely eliminates any notion of craving.

Of course you always have a

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

Professional from academic institutions, pharmaceutical industries, health care indust

choice to eat whatever you wish but you do not need to fear that you wil

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

l automatically substitute “bad” foods for cigarettes, it simply will no

.

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

t happen.

My suggestion? Quit smoking first, then tackle any weight red

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

Companies that provide selfless information through particip

uction issues. Smoking is by far the most immediate threat in most cases

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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