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The concept is simple, the process is complex; but the development of

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

an onsert that affixes to the advertisment within any magazine, exactl

; 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 the same or adjoining page of your advertising. Image the possibil

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

ties and the format. This author has developed exactly that system, bo

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

h the process and the Onsert. I call them Response Triggers, that affi

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

Combination pro

x and adjoin on page, before the signature is folded. Affixing is done

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

at any printing press speed up to 3,000 feet per minute with extreme 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

curacy.

No longer does a magazine publisher have to go offline to inc

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

ude a response device for their advertisers. The revenue potentials ar

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

e enormous and now can be delivered. The same page as the ad; no longe

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

is it required that a bind in run between signatures of a magazine or

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

Following aspects would a

publication. Right on the same page or adjoining page. The format can

dd to the challenges in developing combination products:

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

ffer features and involvement for the reader. It triggers a response.

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

The triggers can be printed on paper, plastic, or foils; on material

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

s light as 2 pt to as heavy as 9 pt. Thickness is only limited by what

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

the magazine will accept for thickness. Adhered with a removalable adh

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

Professional from academic institutions, pharmaceutical industries, health care indust

sive, it doesn't tear its host page. The adhesive also allows the trig

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

ger to be place on most surfaces and moved around; just like a MMM Not

.

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

.

The possibilities are endless!

Write me if you'd like more detail!

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

Companies that provide selfless information through particip

Rich Keefe

rich.keefe@att.net

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

The Global Brand enables organizations to take advantage of economies of scale with regard to marketing investments. The Global Brand is much more difficult to develop. A Global Brand Positioning architecture has four layers. it also has uniform brand name and graphics across all countries. However, the execution of brand communication in each country must take advantage of local idioms and situations to maximize local relevance of the global brand positioning.

Who would ever thought that in the passage of time, fund raising softwares will be created? Nowadays, there are a lot of mushrooming fund raising softwares that can be spotted online.

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