References - Home and Family

Barney the huggable, lovable, purple dinosaur is a success among young children because of his fun and creative

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

way of teaching people to be nice to one another. Barney, Baby Bop, BJ and Scooter show children that coopera

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

Examples of combination products may in

ion, respect for others, self-esteem and good manners are all just as important as staying healthy and safe. 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.

at’s why having a Prehistoric Party starring Barney is a perfect idea for a toddler’s party.

Decorating for a

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

rehistoric Barney Party should include lots of bright colored streamers and balloons. Colors like purple and g

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

Combination pro

een (like Barney) or yellow and red (like B.J.) will keep the attention of even very young children.

Possible

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

party game ideas for a Barney theme celebration would include:

ARCHEOLOGIST GAME: Have guests participate in a

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

dinosaur egg hunt. Eggs could be out of marshmallow rice cereal treats and shaped like eggs. Colored rice cer

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

al would make the treats look spotted like a dinosaur egg. Make sure that eggs are wrapped up tightly in saran

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

style cling wrap so that the eggs can double as no only scavenger hunt targets, but also party treats – YUM!

I

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

E AGE PARTY GAME: Have guests dance around the room to music (preferably Barney songs, of course). Then, sudde

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

Following aspects would a

nly stop the music. Guests must freeze instantly in place because they have been struck by the ice age. Anyon

dd to the challenges in developing combination products:

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

caught moving after the music stops is “out.” Game continues until only one guest remains to be declared the

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

inner.

NO GRINS ALLOWED! ACTIVITY: Sit the guests in a circle so they can see each other easily. One guest is

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

declared to be the “goof.” All the other guests must put on a sad or frowny face. The goof then spends 30 se

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

onds trying to make the other guests “turn their frowns upside down.” The goof can use smiles, giggles, and f

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

Professional from academic institutions, pharmaceutical industries, health care indust

unny faces to get the other guests to break their frowny faces. Of course, any guest who is caught with even t

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

e smallest grin is declared out. After the 30 seconds is up, the goof wipes his smile off with his hand and 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

ows it to someone else who is now declared the goof. The game continues until no one is left frowning and ever

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

Companies that provide selfless information through particip

one is “out.” Luckily, by the time everyone is “out” they are so busy laughing that no one seems to even mind

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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