Social Space - Home and Family

You have decided to dig into your family history. Your notebook contains everything you could recall about your relations. You began by recording your vital statistics and proceeded backwards jotting dow

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

n all the details you could think of. So where do you go now?

Have you rummaged around your home to locate any documents that can support the information, provide clues to work with or add interest and

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

Examples of combination products may in

personality to the history you are compiling? You probably got out a birth or baptism certificate and a few old photos then concluded that is all you have to contribute. You are ready to make a trip to y

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

ur parent’s house or some other relatives to discover what treasures they have. STOP! Go back and look again. This time gather up everything you can lay your hands on that may (even remotely) add some in

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

terest or provide clues.

You are not ready to interview family until you have established every thing you know. If you want to produce a family history ... you want to find out more than the vital event

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

Combination pro

. With genealogy you start with yourself and with family history you do too.

Most of us do not truly start our research with ourselves. We know what we do for a living and where we went to school. What

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

about the future generations? A family history is not just for you … it is for your descendents and other kinfolk who will come after. Do a thorough investigation of your own life first. Not only will yo

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

u establish a good foundation for your family history, you will learn what to ask others. When it comes time to contact other family members, you will have specific questions in mind. You will also have

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

background of material to work with that can be helpful in triggering memories.

Hunt through your files, drawers and closets. Locate that box of childhood mementos. Pull out a copy of your resume. Take

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

a close look at your keepsakes or family heirlooms.The items you gather will help to create a comprehensive documentation of your own life. You will find that the list of possible resources is endless -

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

these include more then official certificates and photographs. Look for report cards, school papers, newspaper clippings, postcards, letters, insurance papers, licenses, property or business records, dia

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

Following aspects would a

ries, old passports, calendars, address books, and greeting cards. Even awards and trophies are records of events you should note.

Once you have gathered up all the bits and pieces of your life - study

dd to the challenges in developing combination products:

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

each one. Use them to help recreate your story. Note down the mundane and the exciting. As you do not live in a world by yourself, you will probably be coming up with plenty of stuff on other family memb

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

rs. This is okay. You will find as you get deeper into your family history that while looking into the life of one member of the family you will discover information about not just them, but other kin. T

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

ake meticulous notes – of everything that comes to mind.

This may all seem a bit much to you. You might think it does not matter that when you were young you won a bowling trophy in the town league. Whe

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

her you studied piano, made model airplanes, are an excellent cook, can rebuild a car motor from the ground up, or collect salt and pepper shakers… it all counts. What you do, have done and enjoy doing,

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

Professional from academic institutions, pharmaceutical industries, health care indust

should go into your family history. This information gives insight into you as a person.

You might even want to include some interesting anecdotes. All those documents and other mementos probably have y

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

ou reminiscing. Write it all down. These memories will bring your family history to life.

Remember start with yourself. Make note of the exciting and the trivial. If you feel funny musing over your life

.

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

by yourself, get your spouse, sibling or child to sit down with you. Let them take the notes. Just put it down on paper.

You have stories to share that will mean much more to others than the date you we

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

Companies that provide selfless information through particip

re born on. After you have completed this groundwork, scrutinize what you wrote to uncover the questions you will ask others. Make a list of these questions.

Now you can move on to 'interviewing' others

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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