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It might seem like the simplest thing in the world, but saying sorry and meaning it is much more than the uttering of a single word. We seem to live in a world where folks are more self centred, selfis

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

h and self seeking than at any other time, so it's little wonder that so many of us are stepping on others toes and finding it necessary to keep apologising all the time.

A few years back, just before

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

Examples of combination products may in

y wife left me, I can recall her saying that she was sick and tired of my broken promises and weak apologies. In fact she asked me to stop saying sorry as it meant absolutely nothing anymore. I'd love

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

to sit here and write about how wrong she was, but if the truth be known, she was absolutely right at that time. Sure I used to say sorry a lot, but if I'm honest it was to keep here quiet rather than

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

omething I was sincere about at the time.

Many of us are so wrapped up in our own little worlds of I, I, I, me, me, me, that it's becoming increasingly more difficult to form 'real' relationships with

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

Combination pro

ther human beings. It could be related to the pressures of modern day lifestyles where we have become addicted to 'more', or it might be that it's just too easy to shirk away from our responsibilities

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 such an extent that we've adopted a couldn't care less attitude. Who, really knows, maybe know one!

Although we can't change who we are, we can reinvent ourselves to a degree and work towards an ad

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

ustment of attitude. Some of the happiest people I've ever met in my life are those that spend more time thinking about others than they do themselves. Living a life where you do not have to constantl

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

apologise for your misbehaviour can only be fruitful in the long term, both for you and those around you.

But none of us are perfect and apologies are necessary from time to time no matter who we are.

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

I probably used to apologise countless times daily simply by uttering the words under my breath. Sorry about that, sorry about the other day, sorry about this morning, sorry I shouted, and so on and s

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

forth. I rarely made eye contact, I'd probably utter these words whilst still moving and I perhaps even forgot sometimes what it was I was apologising for. In other words – meaningless!

A therapist

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

Following aspects would a

once taught me that to say sorry was not enough to convey true regret. Even if you meant it at the time, it's pretty meaningless to the other person. She went onto say that before you make an apology,

dd to the challenges in developing combination products:

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

you first need to think about what it is you're apologising for. Next you need to find the appropriate moment to make your apology. Once the previous things are sorted, it's recommended you sit the oth

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

r person down and look them straight in the eye and say words to this effect. "I would just like to sincerely apologise about X. You were right and I was wrong and I'm truly sorry for the way I reacte

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

to the situation".

Sounds simple doesn't it? But if it's not your usual way of addressing things, it can be really difficult to carry through, believe me. The therapist went on to say that even if y

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

u don't mean it at the time, still do it. Fake it until you make it I think she said.

Well, I took what she had to say on board and to be honest I would have sooner chewed on a broken glass sandwich t

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

Professional from academic institutions, pharmaceutical industries, health care indust

han gone through that first ordeal. However, she was right, and I did continue to fake it until I made it, but make it I did. Slowing down and communicating with others at a deeper level has helped me

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

to get out of my own head and to become a more considerate person as a result. Also, because a genuine apology is no easy picnic, I'm now very mindful of the way I treat and speak to others therefore re

.

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

ucing the risk of having to make an unnecessary apology.

If you find you have to apologise to other people way to much, maybe it's time to step back and take a look at why. The chances are you get res

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

Companies that provide selfless information through particip

less, irritable, and discontent when things don't go the way you want them to and that is called self. Once you can unshackle from the bondage of self, your life will improve beyond your wildest dreams

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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