I Advice - Health and Fitness

While there is nothing easy about the process of smoking cessation, the concepts involved a

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

re simple. And the basics of successfully stopping should be stressed over and over again t

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

Examples of combination products may in

o folks who are looking to make this drastic but important change in their lives.

In the f

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

irst three months after you quit smoking, you should know that you might not feel like your

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

self. You are likely to feel lethargic, short-tempered, irritable and frustrated. Expect to

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

Combination pro

have these feelings and just accept them as part of the process.

Some basic things that y

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

ou will need to do while you are quitting smoking are:

· Exercise (Take walks, go for a bi

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

ke ride, attend a dance class)

· Stay busy (Take up a new hobby or start a project)

· Eat

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

regular meal (Feelings of hunger are often mistaken for the desire to smoke)

· Avoid Trig

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

gers (A trigger is something that you associate with smoking)

· Let others know that you a

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

re quitting, many will offer their support

· Have plenty of gum, hard candy, stress toys,

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

Following aspects would a

straws, toothpicks to satisfy your oral fixation

· Consider some form of nicotine-replacem

dd to the challenges in developing combination products:

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

ent therapy

· Join on-line smoking support groups or use Quit Lines (where you can call an

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

d speak to someone when you’re feeling weak)

Another encouraging activity is to take the m

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

oney that you would normally spend on cigarettes each day and put it into an “I did not smo

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

ke jar.” You will begin to see how much money you are saving by not smoking. You may even u

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

Professional from academic institutions, pharmaceutical industries, health care indust

se that money periodically to reward yourself for staying smoke free.

Do several of these

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

things, and I guarantee you that quitting smoking will be a little bit easier. Remember, ma

.

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

ny people are not successful the first time that they quit smoking. If you fail the first t

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

Companies that provide selfless information through particip

ime, just try again. Do not discouraged. Remember, you haven’t failed if you keep on trying

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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