Advice Pool - Reference and Education

Everything you read, hear or see will make an impression on your mind, even if it is on TV,

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

Radio or Movies.

I once went into a book shop and was browsing, looking for something to

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

Examples of combination products may in

ead. I was impressed by the comments of famous people on the sleeve-notes of one book and 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.

bought it on the strength of them.

When I went home and started to read the book I quickl

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

realised that this was not an enjoyable experience. But I carried on reading. All those c

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

Combination pro

elebrities endorsing the book couldn’t be wrong and I paid good money for it.

I persevered

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

to the end of the book but I hated it. To this day, perhaps twenty five years later, I stil

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

l regret reading it. The images, names and characters are still in my brain.

I actually po

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

soned and polluted my own mind. I wish I had stopped reading after the first page and chuck

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

ed it in the bin.

People can also have a negative or positive effect on you. Not everyone

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

who is outwardly bad is really a bad person. And not everyone who is apparently good is rea

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

Following aspects would a

ly so.

Have you ever been in the company of someone who made you feel uncomfortable? You c

dd to the challenges in developing combination products:

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

ouldn’t quite put your finger on it but there was something about them that drained you of

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

nergy. I call these people Psychic Vampires. They often don’t realise what they’re doing.

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

It is best to avoid these people at least until you learn plug the gaps in your energy fiel

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

. Don’t waste your time, your life and your energy on them. These types often like to creat

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

Professional from academic institutions, pharmaceutical industries, health care indust

e a reaction; that is how they steal your energy.

Perhaps they’ll make a joke or throw an

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

nsult. Don’t react, don’t respond, stay centred. Stay in the moment.

When you’ve been medi

.

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

tating for some time and become a stronger individual, you’ll make these types uncomfortabl

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

Companies that provide selfless information through particip

, not by anything you do but simply because you don’t react. But until then, bide your time

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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As a writer or author you may be asked to speak about your book or business either at a book signing or networking meeting. As a business owner, you may have to make a training presentation about the new policies or practices you are setting. It is important to know how to give a good presentation.

When your best friends get divorced it can be a difficult road for you to travel. Get hints and tips on how to do it successfully.

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