Advice Pool - Self Improvement

I am writing this as a result of many emails I have received lately, commenting on the fact that things were not going according to plan for them.

With the vast amount of interest in LOA and associated subjects late

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

ly, it seems that there is more confusion than answers. One of the things that seems to be so prominent, is the fact that everyone has gone into COMPETITIVE mode. This is one of the main teachings of Wally, he states

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

Examples of combination products may in

quite clearly that you should be CREATIVE not COMPETITIVE. Every time we force an issue whether it be financial , emotional, relationship or absolutely anything, we are subconsciously going into COMPETITIVE mode.

I

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

think that we should all just take a deep breath and have a look at the situation as it is now. I am thrilled that there is a huge wave of interest in these teachings and that so many more people are becoming aware.

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

he problem I have is that no one seems to be telling people about the hard work needed to really understand these teachings and make them work for you.

I used the analogy recently of a gym selling the services of a

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

Combination pro

personal trainer. If they said to you, that the next 8 weeks are going to be really hard, you are going to feel absolutely terrible every morning, your body will ache, how ever you feel we are going to drag you out o

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

bed at 6.00 oclock, your muscles are going to burn, we are going to push you harder than you have ever been pushed and when you feel that you have had enough, we are going to raise the bar and push you even harder,

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

etc… You really would think about signing up. When you are in possession of all the facts you can make a calculated decision. Of course the really COMMITED people would sign up and really benefit, but a vast majority

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

would THINK about it.

That is why when you are making your decision whether or not to use a personal trainer, they only tell you about the benefits. You will look and feel fabulous, “Oh great where do I sign?” It is

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

later that you realise the effort needed and many people fall by the wayside, they are not prepared for the hard work to get to the target. That is the same as the sales and implied benefits of these teachings, no o

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

e is telling the truth up front as to what is really involved to understand and learn these teachings.

I can honestly tell you that these teachings when applied correctly and with the knowledge as to how they work,

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

Following aspects would a

are life changing. The learning curve though is anything but easy. Most people do not realise that their conscious mind does not actually make any decisions, that is all done by the past programming that is stored in

dd to the challenges in developing combination products:

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

your subconscious. Therefore however convinced your mind is about doing something, your subconscious always has something to say. Sometimes you do something against what your subconscious advises and all of a sudden

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

you get a queasy stomach and feel very uneasy. It does not matter if what you do is absolutely correct, if your old programming disagrees you will have conflict.

It makes sense then that we should look at our OLD be

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

iefs and see if they have relevance in our lives today. If they do not, we have to WORK on removing them. That is the hard work that is just the beginning of really understanding. How many times have you started to d

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

o something or had an idea and the little voice in your head says, “Don’t be silly, how can you do that , you are just SO and SO from the wrong side of the track, just forget it and get on with things.” We all have a

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

Professional from academic institutions, pharmaceutical industries, health care indust

d they are just ideas and incorrect facts that have been planted over your life to keep you in line. There are so many things that we believe or have been told, that are just not true. Why then do we still listen to

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

them when we are making a decision?

This is one of the fundamental problems with all these new teaching ideas. They tell you to imagine this or that and dream of some fantastic lifestyle in the future and you can ha

.

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 it just by thinking. That is exactly when your subconscious comes in and tells you all the reasons why you cannot do or have what you are thinking. As I said earlier, the facts are that you CAN have what you want,

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

Companies that provide selfless information through particip

but you must believe that you can have it and also be sure that it is what you want.

As an exercise just dig deep and find some of the things that your subconscious uses to hold you back, that you know not to be tru

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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