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Ahhh. A wonderful lesson in gift basketing that I'm happy, and a bit embarrassed, to share with the 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

orld.

I've been making gift baskets from home for just over a year now. And as a home-bas

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

Examples of combination products may in

d gift basket creator, I keep a fairly steady inventory of gourmet food items in my office. I have ev

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

rything from gourmet crackers to cookies, mustards and dipping pretzels, and yummy yet fancy chocolat

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

s from Ghiradelli and Guylian. I've never had a problem with the freshness and quality of the food un

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

Combination pro

il this summer.

Last week, my family took an escape route to the coast to enjoy some 70 d

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

gree weather, as opposed to the sweltering, record-breaking temperatures plaguing the California inla

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

d areas. We enjoyed a wonderful week long trip to the ocean, where the temperature was perfect, the v

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

ew well beyond beautiful.

We were bummed to have to return to the 100 degree heat we were

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

suffering at home...and I was even more upset to find that all of my chocolate inventory had melted!

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

Simple it would have been to refrigerate the chocolates before going out of town...I merely did not e

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

Following aspects would a

en think about it.

Unfortunately, yet fortunately, for me...I've been forced to eat it my

dd to the challenges in developing combination products:

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

elf. Although it's simple enough to refrigerate the chocolates after they have melted to get them bac

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

to their desired consistency, they just don't look the same and are not suitable for placing in my g

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

urmet gift baskets!

This have given me a wonderful opportunity to test the product prior

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

o selling and I can positively tell you now, that even after having melted, the Ghiradelli Squares (d

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

Professional from academic institutions, pharmaceutical industries, health care indust

rk chocolate with white mint filling) are wonderful. And the Guylian Twists (milk chocolate truffles)

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

look nothing like the little sea horses on the package, but they taste just as yummy.

Sev

.

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

ral dollars lost, five pounds gained and an important lesson learned on my part. If you are new to th

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

Companies that provide selfless information through particip

gift basket industry...learn from my lesson. Pay attention to your inventory! It is money, after all

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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Just Answers - Eat My Inventory: A Lesson Learned in the Gift Basket Business

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