Your Space - Self Improvement

There is a massive difference between hoping or wishing for self improvement, or that something will change in our l

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

ives, and actively deciding to make changes in our lives.

New Year resolutions often fall into the wishing and hopi

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

Examples of combination products may in

ng category. If we say ‘I’d like to give up smoking’ or ‘I need to lose weight’ or ‘I really should get fit’ or ‘I s

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

hould get a better job’ our chances of success aren’t great. Why not? The wording alone makes these more like a wis

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

list of things that we think will make us happier if they happened. This is a bit like saying “I’d like to win the

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

Combination pro

lottery” and the very lack of conviction makes their odds of success pretty similar.

These are not decisions. Decis

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

ions are when we say to ourselves ‘I am going to do whatever I have to do to lose 30 pounds in the next six months’

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

or ‘I am not prepared to put up with my lousy job any longer’. We need to decide that ‘enough is enough’ and be a

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

solutely serious that this is what we want. We need to be prepared get any information and help we need, form a plan

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

and be prepared to take massive and consistent action. We need to be 100% committed to our decisions and be prepare

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

d to follow through whatever it takes.

Wherever we are in our lives now, it is due to the decision we’ve made in th

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

Following aspects would a

e past. It can also be due to the lack of decisions we’ve made. Many people drift through life with no real purpose

dd to the challenges in developing combination products:

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

r plans and never really make many, if any serious decisions.

If we want to make positive changes to our lives and

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

have greater success and happiness, there are many self improvement books, audio programs, seminars and coaching pro

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

grams that can help enormously.

However, the first step to making any change is making a decision, whether it’s to

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

give up smoking or start that business you’ve been talking about for years.

We can have access to the best personal

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

Professional from academic institutions, pharmaceutical industries, health care indust

development tools available, but without having made the necessary decisions, little will change. But when we make

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

firm decisions and know exactly what we want, we will find the strength and resources, and take the actions needed t

.

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

o succeed.

Self Improvement Tips Quote of the Day:

”Vacillating people seldom succeed. Successful men and women ar

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

Companies that provide selfless information through particip

e very careful in reaching their decisions, and very persistent and determined in action thereafter.” - L. G. Elliot

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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