References - Self Improvement

Whenever people talk about self-improvement, they ask "How can I get from where I am to where I want to be?"

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

The simple answer to this that you can do anything you want to, if you want it enough and you are prepared t

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

Examples of combination products may in

take the necessary action. For anything to happen you must have two things:

Thought and

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

Action

Everything starts with a 'Thought', but nothing happens without 'Action'. There is a simple

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

formula which I call 'Your Success Principle' that can be applied by anybody to just about any situation. Th

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

Combination pro

s formula brings together the two necessary components of thought and action and provides the means of how to

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

get from where you are to where you want to be.

The first part is your approach and attitude, in other words

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

, the way you think about things. This must be worked on if you are to succeed at moving from where you are t

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

where you want to be.

You've heard about this before, but I'm going to show it to you in a different way. I

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

comprises just three words: the first is POSITIVE which is the opposite of negative and in this case means a

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

cepting that things can be good. The second word is MENTAL meaning 'using your mind', and the third word is A

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

Following aspects would a

TTITUDE. In this case attitude is the way you consider things. So the first part of how to get from where yo

dd to the challenges in developing combination products:

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

are to where you want to be is POSITIVE MENTAL ATTITUDE.

The second part of the formula for your success pr

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

nciple is concerned with what you do about the situation that is causing you the problem and is also boiled d

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

own to three words. The first of these words is SUSTAINED, which in my book means "keep on doing" the things

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

ou need to do. The next word refines the statement by adding MEANINGFUL and focuses you on doing things that

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

Professional from academic institutions, pharmaceutical industries, health care indust

re relevant not just being busy. And the final word in the second part of the formula is ACTIVITY.

The secon

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

d part of the formula is therefore SUSTAINED MEANINGFUL ACTIVITY. Doing the things you need to do that are re

.

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

evant and continue doing them until you achieve the result you desire.

The formula for your success principl

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

Companies that provide selfless information through particip

is therefore very straightforward:

Positive Mental Attitude + Sustained Meaningful Activity = Success

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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References - How to Get From Where You Are to Where You Want to Be

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