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Many people are choosing the option of working at home nowadays. The benefits to working at home are varied for each person. For so

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

me people, they have small children and either can’t afford the high costs of child care or prefer to take care of their children a

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

Examples of combination products may in

t home. For them, working a home is the best of both worlds. They have the benefit of being home with their children while still p

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

ursuing their career. There are others who work at home to avoid the long commute. Our highways are becoming very congested and for

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

some, working at home is much preferable to sitting in traffic. There are others whose jobs have always been flexible enough to wo

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

Combination pro

rk anywhere. Book writers and magazine writers come to mind. They can write from anywhere and do not need to network with others in

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

day to day work activities.

Working at home is not for everyone however. It takes a very disciplined person to be able to set a w

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

ork schedule for themselves and follow it. It becomes very easy to start sleeping in or doing work around the house. To be successf

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

ul, I believe you need to set work hours for yourself and stick to them. This does not mean they are inflexible. One of the reasons

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

you are working from home is for more flexibility. It does mean though that you need to decide you are going to work certain hours

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

and stick to them . Schedule them around your other activities, but don’t start to blow off work if something more interesting com

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

Following aspects would a

es along. You will soon find yourself overwhelmed with tasks that need to be accomplished. If you have an employer, they will quick

dd to the challenges in developing combination products:

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

ly become unhappy if you are chronically behind in your work. If you are working for yourself, you won’t make any money.

It is ver

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

y important to have a quiet work space. Especially if you have children at home. Working uninterrupted is very important. Your chil

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

dren need to know that when you are working, you are not to be disturbed. Having your workspace in a den of library with a closing

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

door is ideal, but most people can find a quiet corner somewhere is a separate room is not possible. My children know not to go nea

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

Professional from academic institutions, pharmaceutical industries, health care indust

r mommy’s desk and not to mess with her papers. I don’t have a separate room, but I manage. My kids are small, so although its neve

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

r possible for me to be totally uninterrupted, they do know that when mommy is on the computer, they are responsible for amusing th

.

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

emselves. I schedule breaks to play with them and generally try to do most of my work when they are in school or sleeping.

Working

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

Companies that provide selfless information through particip

at home can be a great solution for someone who has small children or a long commute. It does take effort to be successful however

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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