E-Articles - Health and Fitness

How would you feel if your child was born with a genetic damage and that if the cause of the damage happened to be you, the father? You and your smoking habit! How 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

ould you feel? However bad you might feel there is nothing you can do about it then, as it would be already late and the damage that you would have caused would be i

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

Examples of combination products may in

rreparable. You would have to live with this guilt through out your life.

Previously it was thought that only women smokers can cause damage to their foetus or to t

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 new born. Yeah, they still of course could if they are careless enough to smoke. Smoking during pregnancy increases the risk of premature delivery, miscarriage, s

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

illbirth, placenta abnormalities and for the baby it increases the risk of low birth weight, sudden infant death syndrome, abnormal lung development, pre-maturity, l

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

Combination pro

ong term growth retardation etc.

A new study by Canadian researchers has revealed that not only women but even men who smoke are responsible for giving a greater ri

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

sk to their offspring. In the test done on mouse which were expose to smoke for either six or twelve weeks, it was found that there were changes in the DNA sequence

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

f the sperm cells. The change in the DNA is believed to have the potential of being inherited by the offspring.

This means that the longer the mice were exposed to

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

the smoke the greater was the chance of the sperm cells undergoing mutation. Lead researcher Dr Carole Yauk said “We have known that mothers who smoke can harm their

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

fetuses, and here we show evidence that fathers can potentially damage offspring long before they may even meet their future mate.” The only way to prevent this kin

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

of condition lies in your hand. It entirely depends upon you, you can choose to be selfish, thinking only about your want, and can continue smoking to cause damage

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

Following aspects would a

to the future health of your unborn child and to yourself in the long run. Or else take up the difficult but promising way by quitting to smoke, whereby making yours

dd to the challenges in developing combination products:

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

elf active and healthy not only for you but also for your coming offspring.

You may quit smoking by your own or by taking the aid of any one of the smoking cessatio

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

n kits or pills available. If you are confused in choosing the right aid you may consult your doctor who will prescribe you the very medication which will be benefic

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

al for you. You may also order Chantix the anti-smoking drug by Pfizer Inc. which is appro

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

ved by the U.S. FDA and has recently been approved in Britain with the brand name Champix.

This is one of a kind anti-smoking drug with Varenicline as its main comp

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

Professional from academic institutions, pharmaceutical industries, health care indust

onent. It is not addictive and is also not a nicotine replacement. Chantix works by sending signal in the brain where by the neurotransmitter dopamine is not activat

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

d. By working on the nicotine receptor, it helps in overcoming the craving
.

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
trong> for smoking and lessens the pleasure attained from smoking. Thus, lessening the withdrawal symptom and giving an awful taste, chantix makes sure that once a p
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
erson quit, he stays smokes free for life.

So stop the mutation of your genes while you can. Stay smoke free and healthy with a smart bright and beautiful offspring

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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