E-Articles - Self Improvement

We always do the best we can with what we have – Ronit Baras

A very common human expression is "I wish I could go back in time and change . Then my life would be different. I wish I

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

could have a second chance". Let's explore this a bit, shall we? Pick an event in your life, which you would give anything to go back to and change. Being unfair to someone close, breaking a leg because you weren't careful enough,

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

Examples of combination products may in

getting caught doing something you shouldn't have done or anything else you wish hadn't happened. Think of what this events caused in your life - pain, embarrassment, failure, etc, and make sure you've chosen an event you feel ver

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

y strongly about.

Now, roll back your life to the point in time just before that event. But here's the catch: you can't take with you any of the knowledge and skills you've accumulated since the event. You must go back to being 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

actly the same you from before the event took place.

Now, ask yourself this question:

Given a second chance, but being exactly who you were then, could you really change anything?

If your answer is "yes",

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

Combination pro

then ask yourself this:

Why didn't you do it differently the first time?

It's OK. Take a deep breath, think about it, and the answer will come ... you couldn't, because you didn't know better, or didn't have

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 required skills and missed by a second, or whatever the reason. If the same you was put in the very same situation exactly, you would get the exact same results as you did the first time. In fact, you could go back there a mil

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

lion times and still get the exact same results. How frustrating! Or is it?

When we've done this little exercise, and when our clients have done it, we've found that, strangely enough, this thought provides total liberation from a

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

ny guilt feelings we may have had. The reason we did stupid, cruel, painful or boring things was that they were the only things we could do at the time. Sure, now we know better, but then, we didn't!

But why stop at a single event

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

? If this is true for one event, isn't it true for every event? Isn't it true for every decision in our life? Isn't it true for every single second we live? Sure it is.

So does this mean that we never ever make mistakes, because w

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

always do the only thing we can do? Absolutely! We always do the one and only thing we can do, and it's always what we consider at the time to be the best thing to do (from our point of view).

Conclusion #1: I'm OK
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
g>

Let's expand this to other people now.

First, we can start with the people we like, because it's easiest to forgive them. You'll quickly agree that the people you like, much like you, always do the best they can, because they
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
are such good people. Even when they make mistakes, it's simply because they couldn't do any better. Therefore, they are OK too.

The next step is a bit harder, especially when we think of people who do seriously bad things, like r
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
ape or murder, but it's as inevitable as all the previous steps. No matter how we may judge another person's actions, the person himself is doing the best he can under the circumstances. No matter how "bad" the other person is, the
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ir genetics, background and experiences have gotten them to do what we consider to be bad, but it was still what they thought best for them.

Conclusion #2: Everyone else is OK

All this is fine and good, but what
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
do we do with it?

Well, accepting yourself (conclusion #1) will help you relax a great deal and increase your self-confidence. It will eliminate guilt, which is a destructive feeling, from your life forever. You will be free to fo
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
cus on getting the best outcomes without worrying about things too much. This will, in turn, improve the results you see in your life.

Accepting others (conclusion #2) will help your relationships tremendously, because you will no
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
longer judge other people's actions and words. You will become very helpful to others, being able to support them in whatever they do. You will be forgiving, because you don't take anyone else's actions personally. After all, they
.

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
are doing the best they can. Forgiveness will help you eliminate anger. This will, in turn, improve the results you see in your life, because people around you will return your kindness and help you too.

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

Companies that provide selfless information through particip
I could tell the world just one thing, it would be that we're all OK – Jewel Everything will be OK in the end. If it's not OK, it's not the end – Ronit Baras

Be happy in life!

Ga

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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E-Articles - I'm OK - You're OK

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