References - Home and Family

In today's "hurry-up-want-it-now" world, making bread, rolls, muffins, or just about anything from scratch is slowly becomi

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

ng a lost art. It's so very convenient to run to the store and grab a loaf of bread or a package of frozen brown-and-serve

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

Examples of combination products may in

olls. Sure, store bought bread products can be "good" for you. But without realizing it, we are sacrificing an opportunity

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

o spend quality time with our families not to mention the money you can save by baking your own bread.

There was a time wh

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

n virtually everyone made his or her own bread, but this once common household activity has been lost, and given way to con

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

Combination pro

enience. Baking successful bread recipes from scratch can not only give you a feeling of accomplishment, but it can also be

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

a fun, wholesome activity that the entire family can enjoy! Young children are especially eager to "help you" and you may b

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

surprised at just how well they do!

Children love to help us do things. They seem driven to please their parents, and the

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

have an inborn need to feel useful. I have three children. At twelve, eight, and five years old they are always ready to h

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

lp me whether I need it or not! ;)

There couldn't be a better activity for family togetherness than baking bread (or a nic

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

pan of cinnamon rolls for that matter.) Baking bread is like being in a play, there is a part for everyone. From the young

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

Following aspects would a

st to the oldest in the family, there is a part that everyone can play. Just watch your little one's eyes light up when the

dd to the challenges in developing combination products:

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

tap that teaspoon of salt or baking powder into the mixing bowl!

Children, if you give them a chance, are great helpers i

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

the kitchen! They can't wait to get their little fingers sticky, measure a teaspoon of this or a cup of that, and they are

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

especially good "watchers" when it comes time to pull a pan of rolls or a loaf of bread out of the oven. Their skills at ta

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

ting a fresh loaf of bread or a steamy cinnamon roll are unmatched! Smiles are mandatory.

This is quality time: spending t

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

Professional from academic institutions, pharmaceutical industries, health care indust

e afternoon together with your kids (and your spouse), regardless of the accidents or the mess, never mind the sprinkles of

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

flour on the floor, or the argument over who got to turn on the mixer. The point is that you were there sharing a precious

.

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

oment with your family. Your reward is a gentle hug on the leg, a sticky kiss, and the words "I love you".

This world of c

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

Companies that provide selfless information through particip

nvenience robs us daily of the activities that were once a mainstay. How many precious moments have you lost to convenience

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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There is always someone who is willing to help you in overcoming your troubles. Talk to your friends, family, fellow workers or even to various help groups and associations.

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