Advice You - Business

During the 1950's Korean Conflict, six American GI's were assigned to a housing unit. Fi

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

ghting had calmed down, so they found themselves living in close quarters with extra tim

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

Examples of combination products may in

on their hands.

Predictably, they soon started playing practical jokes on each other..

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

.sneaking up on each other, rubber snake tricks, etc.

Quickly tiring of these games, th

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

y started pulling these little pranks on their houseboy Wan. They liked this good nature

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

Combination pro

d Korean boy-happy to have the job-and figured they'd include him in their practical jok

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

s.

They would tie his boots together while he was sleeping and make loud clanging noise

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

s with their mess kits. Wan would jump up, thinking the enemy was attacking, and fall ri

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

ht on his face. Ha Ha!

They'd hang a bucket of water above his door and place a trip co

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

rd in the threshold. Then, they would call Wan into the room, and watch him get drenched

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

One day the soldiers were sitting around drinking, and someone commented that Wan seem

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

Following aspects would a

ed a little down. They quickly realized that the cause of Wan's depression was the pract

dd to the challenges in developing combination products:

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

cal jokes they had been playing. They had only meant to make him feel included, but obvi

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

ously he only felt humiliated. The soldiers apologized and promised never to do it again

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

Wan's quick reply was "Ok, GI...then I'll stop spitting in your soup." Gross but poign

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

ant.

Anytime we deal with others in an unethical, or manipulative manner, we risk the s

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

Professional from academic institutions, pharmaceutical industries, health care indust

me fate as our GI friends.

Maintaining an attitude of integrity, ethics, and fair deali

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

ng in any negotiation is not only the right thing to do...it's the least costly in the l

.

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

ng run.

Remember what mom said..."Be nice..." Not only is mature adult conduct in negot

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

Companies that provide selfless information through particip

iations its own reward...You'll avoid people spitting in your soup.

Bio

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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Advice You - Spitting In Your Soup

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