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There once was a cynical farmer who was tired of being told how to grow his crops and man

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

age his farm. They knew nothing about his particular plot of land. Then again, those peop

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

Examples of combination products may in

le were the only ones to talk to for miles around. Like most people who are bored with th

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

ere life, that farmer really wanted to meet new people and get some advice from a real ex

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

ert.

One day he read in the newspaper that a traveling antique appraisal fair was coming

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

Combination pro

to a nearby town. This was his chance to hear about more than how to grow his crops. The

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

farmer searched his house for anything that he could bring to that fair, but he was as p

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

oor as a farmer could be.

After a few hours of searching, the farmer found a bronze stee

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

and a ceramic rooster. That wasn't much to show for a lifetime of work, but it's a good

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

reason for going to the fair. Right off he knew that they weren't worth much, but going t

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

o the fair is all that the poor man could afford.

On the day of the antique fair the far

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

Following aspects would a

mer walked the twenty miles to town, and after waiting in line for two hours he finally h

dd to the challenges in developing combination products:

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

d his chance to talk to that expert. He proudly placed his bronze steer and his ceramic r

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

ooster on the table and asked for an honest determination of the worth of his items.

The

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

antique expert told the farmer that his items weren't worth, on a good day, more than a

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

buck each. Then, the farmer asked what they were worth on a bad day.

The expert offered

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

Professional from academic institutions, pharmaceutical industries, health care indust

buck for the lot and hoped the farmer would leave so he could see some other items. The

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

farmer asked for a buck and a half. The expert then offered fifty cents and then asked 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

e farmer why he wasted his time to bring such worthless junk to the fair.

The farmer sai

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

Companies that provide selfless information through particip

d that he wanted to hear a cock and bull story from a real expert, and that's what he got

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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Human Resource management is definitely one of the most important branches of any organizations. In this article I will discuss how hr principles can be implemented on practice using Xerox as an example of the successful strategy realization.

Learn simple and easy-to-implement practices that encourage you to slow down and enjoy the moment.

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