Advice Pool - Relationships

Who Broke Your Heart?

Okay, this is a tough one. Stick with me, because this is a bumpy ride.

Ready? Here we go…

If you’

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

ve had your heart broken, you must take responsibility if you’re ever going to get over it.

Phew! I said it! But read it c

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

Examples of combination products may in

refully.

I didn’t say take the blame, I said responsibility. They’re not the same thing. Responsibility is the ability to

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

espond – which means you can make different choices next time. Blame is just being angry either at yourself, another or some

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

intangible such as God, the weather, your time of life and so forth. Not helpful, in the sense that that doesn’t give you an

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

Combination pro

thing to work with.

To heal from heartbreak go back in your mind to when you first met – your first awareness of attraction

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

or this other person. Whatever you saw in them was a direct reflection of whatever was going on in you at the time. You’ll

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

eed to be brutally honest with yourself. (Told you it was going to be a bumpy ride, didn’t I?)

Honestly, were you aware of

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

sense, for example, of “he (or she) will do”? Did you in some way settle for second best? If you did, you considered yours

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

lf second best!

Did you think they were perfect, or in some way better than you? Did you put him or her, mentally, on a ped

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

stal? If you did, once again you weren’t on equal terms, and sooner or later, they were bound to fall from that lofty place!

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

Following aspects would a

Did you take love that was offered when you weren’t sure you had it in equal measure to give back?

These are tough, tough q

dd to the challenges in developing combination products:

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

estions, and I’m not giving them out so you can beat yourself up. They’re so you can polish up your image – to yourself.

On

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

e you’ve done that, you’ll shine! (What else would you expect from a polished image?)

If you’re serious about getting yours

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

lf back on the road to love after a break-up, do yourself a favour and read my book, “How To Love Again When Your Heart’s Bee

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

Broken.” I can’t put the whole thing in this brief bulletin, but the link is on my website: http://www.wizardofwisdom.com.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Just to make you feel a little better before I leave you, though, think on this: whatever the other person did or didn’t do t

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

at contributed to the break up, (or break down), of your relationship is something they have to live with forever. You don’t

.

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

As a very dear and wise friend once pointed out to me: s**t sticks and it’s smelly. But if it’s someone else’s you can was

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

Companies that provide selfless information through particip

it off and then you’ll be clean again. They, on the other hand, will still be full of it!

Trevor Emdon, (Wizard of Wisdom)

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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At around about the time of the Second Catharis, the antagonist's true self is revealed and it normally turns out that the antagonist resembles, is familiar with, mirrors, is a shadow or similar of the hero.

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