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Attitudes are more important than facts.

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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

EM>Dr. Karl Menninger

Attitudes are intangible

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

Examples of combination products may in

and highly personal. They’re based on your experience, bu

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

more importantly, on your interpretation of that experie

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

nce. That is, how you understand the “facts” of a given

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

Combination pro

situation. People who interpret the facts of their experi

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

nce positively tend to be self-confident.

Not su

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

rprisingly, the best predictor of success is your level o

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

f confidence. Confident people tend to initiate action an

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

control their environment--even under difficult conditio

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

ns. Your degree of self-confidence will determine the kin

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

Following aspects would a

ds of risks you take, the amount of effort you’ll expend,

dd to the challenges in developing combination products:

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

and the strength of your perseverance in time of trouble.

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

Your confidence will determine the amount of flexibility

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

you creatively apply in new situations. Your confidence

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

ill promote either optimism or pessimism and will dictate

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

Professional from academic institutions, pharmaceutical industries, health care indust

the degree to which you are vulnerable to debilitating s

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

tress or depression.

No one can give you confide

.

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

ce. You must create it yourself. You can start by discove

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

Companies that provide selfless information through particip

ring your strengths in the “facts” of every situation.

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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