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I freely confess that I have had a life-long love affair with words. I fell in love with words by the flickering light of a pine-knot fire. I watched my story-t

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

elling father use words to hold the neighbors captive. I learned how to use them from anybody who could teach me.

Words have been used to support and praise me.

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

Examples of combination products may in

They have also been used to attack and wound me. But I have never lost faith in their power or their durability.

Words can reveal thoughts, conceal pain, paint

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

dreams, correct errors, and pass along dearly bought lessons to the latest generation. Words can transport knowledge from the past, interpret the present, and sp

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

eak to the future. Words can build walls between people, or bridges. Words can tear down or build up, wound or heal, tarnish or cleanse.

The ability to use wor

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

Combination pro

s can endear you to your fellows, win them to your side, and enable you to rise to heights you may now only dream of. That happened to my father's son.

Pursuing

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

the mastery of words is worth all the time, money, and energy that you can muster. And what you invest will be repaid with interest compounded.

Build up your kn

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

owledge so that your words are true. Nurture your spirit so that your words are kind, strong, and wise.

The world may little note nor long remember what you say

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

here. And yet it may. For words, once they are released, take on a life of their own, and find lodging in places and hearts you may never know. But after many

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

ays, they may return to haunt you, or bless you.

Think carefully before you let them go.

Below is a short piece from the April 2005 issue of The Achievement Dig

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

st (TAD):

LINCOLN'S LOG: "Effective Communication"

Lincoln's law partner William Herndon wrote: "He loved the study of grammar, which some think the most arid

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

Following aspects would a

of subjects."

Actually Lincoln was following the advice of Hugh Blair, whom Lincoln had read, who had written: "He that is learning to arrange his sentences wit

dd to the challenges in developing combination products:

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

accuracy and order is learning, at the same time, to think with accuracy and order."

Lincoln read aloud to himself in order to get a feel for the sound and logi

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

of his words, and he wrote out his ideas as a way of arranging his thoughts.

Lincoln was not a good speller, but he took great pains in choosing his words. In o

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

ne of his debates with Douglas, Lincoln accused his opponent of being sloppy about this. As Lincoln put it, a horse chestnut is not the same as a chestnut horse.

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

Here again, Lincoln was following Hugh Blair, who wrote: "Hardly in any language are there two words that convey precisely the same idea; a person thoroughly co

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

Professional from academic institutions, pharmaceutical industries, health care indust

versant in the propriety of language will always be able to observe something that distinguishes them...The bulk of writers are very apt to confuse them with each

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

other, and to employ them carelessly...Hence a certain mist, and indistinctness, is unwarily thrown over style."

If you are interested in Lincoln's communicatio

.

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

techniques, check out the DVD and CD "LINCOLN ON COMMUNICATION." This resource is widely used as a training film for leadership and communication programs. www.

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

Companies that provide selfless information through particip

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

A Key Performance Indicator (KPI) is neither a Goal, nor a Key Result Area (KRA), nor a Target, nor a Result nor a Critical Success Factor. And yet these terms are often used interchangeably with a KPI. A KPI defines itself, to a large extent, by its name; it is a performance indicator, i.e. the performance of the process it is measuring should be clearly indicated by the KPI.

Crisis mis-management is the result of a management style that fails to consider a variety of forces at work in organizations today. Many executives and managers that I have interviewed during may career seem to have had a romantic love affair with this style of decision making, delegation, policy making and utilization of corporate resources. They seem almost proud, that this is the way they run their organizations.

Debt is a four-letter word we all want to avoid. However, the cost of living alone is so demanding that debt follows us wherever we go. We have to pay bills, pay for clothing, food, gasoline, taxes, rent, mortgage, car payments, college, etc, that sometimes it is next to impossible not to find yourself humming this four-letter word.

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