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People are always blaming their circumstances for what they are. I don't believe in circumstances. The people who get on in this world are the people who get up and look for the cir

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

cumstances they want, and, if they can't find them, make them.

- George Bernard Shaw

I don't know about you, but there are some things in life that just drive me crazy!

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

Examples of combination products may in

ome of them are big things (like the amount of bad news on the news) and some of them are little things (like how my kitchen bench just never seems to be cleared of everything!).

When

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

I first did my coach training we learned that these are tolerations - the things we are 'putting up with' that we really don't want to. And we went through a process that I must admit

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

I haven't been through in a while - but the difference it made when I first did it was unbelievable . So I commit to doing the 'toleration dance' this week. I invite you to dance alo

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

Combination pro

g with me. Here's how it goes...

Start by writing down everything that comes to mind that you feel you are putting up with. Of these tolerations (and any more that come up in the pro

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

cess) split them into three columns.
1. Ones that you can put up with for a bit longer (providing other things are taken care of),
2. ones that you know you need to work on

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

ver the short to medium term and
3. ones that have to stop right now or something serious is going to happen

Make sure you take ownership that these are things you are tolerating

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

without playing the blame game. For example, if you're annoyed that your kids never pick their towels up it is obviously their action - but it's your re-action that is the toleration.

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

You may end up with a list that's hundreds of tolerations long - don't be overwhelmed. Just be grateful that you can recognize them.

Once you see them in writing (which in itself ca

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

be an eye-opener) it's time to get creative. Start with the ‘Serious' column and take them one at a time. For each toleration the idea is to come up with a way for you to not be tole

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

Following aspects would a

ating this anymore.

It may mean open communication with someone (perhaps even yourself). It may mean doing things a different way. It may simply mean looking at things a different way

dd to the challenges in developing combination products:

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

. It may even mean that you decide it's NOT a toleration, but a choice. You may decide it's the price you choose to pay for spending time on a more important project.

One thing to wat

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

h out for is the ‘shoulds'. If you hear yourself saying ‘I should do, or it should be' you need to stop and find out what's behind the should - either you choose to or you choose not

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

o - should takes away your power, choosing gives it back.

Another thing to be aware of is judging your solutions too quickly. Don't dismiss an idea immediately just because you think

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

it sounds silly or too hard. Out of that idea another one may come up that makes perfect sense.

This isn't going to happen over night - sometimes you will need to sit with a tolerat

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

Professional from academic institutions, pharmaceutical industries, health care indust

on for a week or more and let your sub-conscience go to work on it. If you've got supportive friends ask for their help in brainstorming ways around the toleration. That can be really

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

effective - and a lot of fun.

Leap 'n' Bound: This is a ‘take action’ article. Don't just sit there and nod and say 'sounds wonderful'. If you want to start making a differen

.

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

ce in your life then you need to start doing things in a different way. This exercise could be the beginning of a wonderful thing :). Have you got your paper yet?

This is just one ex

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

Companies that provide selfless information through particip

rcise you could try. As with any coaching you can choose to tackle it... or not - despite my strong plea above ;). Your life is entirely in your hands. Don't you love responsibility

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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Many people believe that first world nations need to think more globally and that does make sense. Of course the bumper sticker that says think globally and act locally is probably also a good idea.

It is best to understand the market forces inhererent in your carefull investment plans and strategies. Understand the concepts of prices , overvalued and undervalued pricing structures as well as the role of analysts in shaping the price structures of your investments.

A large number of UK insurance companies offer specialized insurance for sports cars. These insurers require previous experience with a sports car along with the exact car specifications before offering a quote.

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