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There's been so many times when we've gotten ourselves in trouble, when we've lost lives, money and time, over the assumptions that we've made. It has come to a point when we'd say that "assume" is "ass-u-me". It mak

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

es an ass out of you and me.

Assumptions are derived from experience, and from formal schooling. Both of these sources, unfortunately, are coloured by factors of culture and knowledge limitations.

The culture we gr

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

Examples of combination products may in

w up in influences what we experience (the general Singaporean realises early in his life that it's best not to question too much) and also our formal schooling (American curriculum tends to be pretty inward-looking,

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 the point that understanding of close neighbours like Canada and Mexico could be distorted...and we will not talk about China).

Similarly, knowledge limitations influence our experience (would you dare to venture

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

where you do not know?) and also formal schooling (18th Century Astronomy in Europe indicated 6 planets in our Solar System - no Uranus or Neptune).

And so we carry our set of assumptions with us throughout our live

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

Combination pro

, making changes whenever new experience or knowledge require us to make adjustments and come up with new assumptions. The discovery of Uranus, for example, upsets all calculations, and the new assumptions derived re

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

ulted in the discovery of Neptune, and later Pluto (which is no longer a planet).

In management, some of us have gotten admonished, "Don't assume - ask." I disagree with people who make such statements. Our lives ar

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

governed by assumptions - it's impossible not to make assumptions!

Imagine the very simple act of eating a slice of bread. We assume that the act of eating it would nourish us, and the process of eating it would be

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

good, based simply on previous experiences with it.

But wait! Are you sure the bread has not been tampered with? Are you sure the ingredients are not tainted with rye or some other hallucinogens? Are you sure the ye

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

st is ok? Perhaps the person making the bread has HIV and a cut? Perhaps the baking process was improper? Don't assume - ask! But goodness, how do we know whether the person we ask are either not lying or else knows

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

he whole truth?

Or how about getting into the elevator? How do you know it's safe? Has the maintence been done? Was the maintenance done properly? Perhaps a freak accident just 10 minutes ago has weakened the cable

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

Following aspects would a

onsiderably? Perhaps the electrical circuit is going to blow a chip soon (but passed the test because it fits into the requirements?)? Could you trust that certificate of maintence signed by the supervisor? Paranoia

dd to the challenges in developing combination products:

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

ets in, and you'd rather take the stairs. But you're sure the stairs are not going to collapse any moment?

You'd never get to get that slice of bread if you cannot make the assumption that it should be ok. You'd nev

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

r get to your apartment unless you make the assumption that, generally, the lift should be safe. Our life is based around assumptions, so to tell the person who made the mistake that he's wrong in assuming is very ba

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

leadership.

Someone was once asked, "How do you avoid bad mistakes?"
"By having plenty of experience."
"And how do you get plenty of experience?"
"By making plenty of bad mistakes."

I've heard also

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

he story of this executive who has just make a decision that cost the company several million dollars in losses. Ashamed of himself, he went to the CEO to tender his resignation. The CEO glared at him and yelled, "I'

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

Professional from academic institutions, pharmaceutical industries, health care indust

e spent millions of dollars in educating you and now you want to leave? Get out of my face and get back to work!"

A manager who understands this part of life tries to cover as many possible assumptions as possible w

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

th his new subordinate. An organisation handbook or the department Standing Operating Procedures (yes, my dear military friends, SOP is not Standard Operating Procedures - they are standing because

.

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

hey are always in place) would be of great help to the new subordinate. He would also understand that he'd need time to make his bad mistakes and gain experience.

The good manager gives his subordinate that space to

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

Companies that provide selfless information through particip

make the bad mistakes and covers for him. Such managers can give his subordinates the badly needed space to learn and become better persons.

I think asses make great pack animals and companions, if you allow them to

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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EFT (electronic funds transfer) refers to monetary transfers between different accounts via electrical signals and secured codes. These electric payments are a fairly new means of money transfer, and can be used to pay taxes, make personal, and company payments. Electronic funds transfer systems, include a large number of financial transaction systems. These include fund transfers amongst major banks and transfers among the Federal Reserve Banks through their private network. They are commonly termed as Fed Wire transfers. Other financial institutions are also encouraging the use of EFT. ACH-Debit and Credit departments honor the use of EFT.

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The blazing heat of summer as well the frequent heat waves that racks the state has brought back the popularity of ice cream as a way to escape the heat. Not only that, it seems that sugar free and fat free ice creams are losing ground in favor of the old tasty, sweet and full ice creams we liked so much when we were kids. This is not really so surprising. With the increasing problems we are having with the economy and the increasing pressure to manage our finances, ice creams represents a cheap and effective way to chase away the blues.

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