Just Answers - Writing and Speaking

When vegetarians want to be insulting, they call anyone who disagrees with them a 'carnivore'. That's inaccurate. No human being is a carnivore. People are omnivores. Generally speaking, -if you look around the world - you see that people eat both meat and veget

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

ables, also fruit, nuts, and in most cultures, dairy products. If you want to find a carnivore, you'll have to look at wild dogs and big cats, like lions and tigers. Small predators, like foxes, have been seen to eat roots and plants when hungry too. Most scaveng

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

Examples of combination products may in

rs are carnivores as well. You think fish are? You remember that scene in the film 'Jaws' where they slit open the belly of the small shark hanging up on the pier? I can't remember exactly what came out, but it included a car number plate, a rubber tyre and sever

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

l bits of wood, and sharks are thought of as carnivores, right?

Yes, but people aren't. Still, it's a common trick – accuse people who disagree with you of something that isn't true, but plainly derogatory and is a bad thing in itself. In the case of publishers,

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

the word that they have for Internet Authors is simple and insultingly negative. It is 'wannabes'. The reason? Traditional Publishers cannot imagine a reason why any writer would want anything other than to get a contract with one of them, an established publishi

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

Combination pro

g firm. In that case – they reason – having a presence on the internet and starting a web site is not important and doesn't lead anywhere. In fact, it could only possibly have one of two purposes. One, to get publicity for a would-be author before landing their l

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

nged-for publishing contract. Or, number two, a web site can be used (later) to publicise a book that's been published, after that 'all-important' contract has been landed.

Let's look at these possibilities one at a time. The idea that a web site can get an unpu

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

lished author a publishing deal is rational. It has been borne out in recent years. For new hopefuls, it still seems a good idea. Less than 12 months ago, I would have said I was doing the same. Now things are different. Once I found out about the other possibili

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

ies on the internet, it soon became an end in itself. If a publisher spots my web site now, well, that's interesting – but not necessary. There are enough rewards from a web site to make it worthwhile on its own. It has become – much to the publishers' chagrin -

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

n end, as I said, not merely a milestone along the author's career path. It's no longer the case that 'all roads lead to the publishers' door'. There are other roads to travel.

Second, many published authors find themselves building, or commissioning, web sites,

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

once their books have been released onto the market. Far from being a healthy sign, that's much more a symptom of despair, surely? If publishers were doing their job, then they would be publicising their new-found talents, especially on the website belonging to t

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

Following aspects would a

he publishing house. If 'big name' publishers are advising the people they take on to 'go out and get themselves a website', it's clear that their own publicity machine isn't effective enough on its own. (It's also a sign that there are customers out there on the

dd to the challenges in developing combination products:

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

web, people who look first on the internet when choosing what to read – people that aren't being reached by the 'conventional' means employed by Traditional Publishers, like newspaper reviews.)

If anything, new authors these days are not 'wannabes' but 'wannahav

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

s', in the sense that they 'wanna have' a career in writing, or they 'wanna have' a book for sale. The one thing they don't need to have is a publishing contract. That's certainly one route to getting their book to the reading public, (and always has been), but i

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

the Brave New World of computing and international communications, it's only one way of doing it, not the only way.

Really, it's a problem of blinkered vision and the self-assurance of the new convert. They say that there is no one more convinced of the rightne

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

s of their cause than someone who has recently joined it. This might explain why the newly-published author, clutching their vital new contract, cannot believe that there can be anything better than the road to Traditional Publishers (which they have gone down).

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

Professional from academic institutions, pharmaceutical industries, health care indust

lso, the newly-employed worker in the world of Traditional Publishing cannot understand that there can be anything better than the structure we have been labouring under for two hundred years for getting books to market. Just so, the freshly converted vegetarian

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

is adamant in the rightness of their beliefs and the incomprehension that any sane person would think anything other than what they believe (now).

But they're wrong. No, they're not wrong in thinking that the things they think and do are good. Or that they are r

.

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

ght for them. But they are mistaken – dead wrong – in thinking that there is no other way – of living, of being oneself, and being true to one's beliefs. In fact, they know that isn't true, for they just left that other world behind them. Perhaps because of that,

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

Companies that provide selfless information through particip

they turn round and condemn their former beliefs, pick fights and call names. It's understandable, but misinformed. Internet Authors aren't carnivores. Just a selection of skilled and talented people who've found a different way of getting to where they 'wannabe'

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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