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The boiler died a few weeks ago. Thankfully, however, not during the depths of a cold spell or the winter. Anyway, during the interim period before the heating-system can be replaced, it's the Immersion heater to the rescue. The trouble is that He seems to have developed a problem - a rather vital problem - his thermostat seems to have died... The

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

Sympathy of Machines?

You may wonder - incorrectly, as it happens - as to whether I live in some dilapidated old garret. Good point... except I don’t… but I do freely admit some of the stuff may not be state-of-the-art. But there again, I’d always prefer to have some beautiful objects around and near me - another bit of beautiful glass maybe, perh

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

Examples of combination products may in

ps another beautiful bit of china - than status symbol mod cons. They simply don’t interest or motivate me much! Beauty does.

As I was saying… so, at the end of those days when you’ve worked really hard and concentrated at 4580 degrees, I, like many of us, love to languish in a hot bath full of whatever cocktail of aromatherapy oils I’ve been incl

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

ned to mix to suit my mood that day.

It’s wonderful, great cast iron bath, so I always draw a depth of hot water alone to heat it a bit before I fill it up: I’m not very keen on slithering in only to find my backside parked on against a stone cold base of iron!

So… hot tap on! Hmmmmmm! The clouds of steam that quickly belched out of the hot tap a

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

peared more as though spurting from a volcanic geezer! Within seconds, the bathroom looked more like an exotic spa steam room… I myself, engulfed in a sea of boiling mist, more like a figure in a shipwrecking tragedy than someone trying to relax! Unable almost to see the door, window or other point of egress, it hit me! No! Not the door… but an ide

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

Combination pro

a!

It hit me… that I’d felt this feeling twice today already……. On the Internet! (And no! my system isn’t so old as to have been steam-powered…) … Mentally I’d felt suffocated whilst viewing a few websites… of certain peers and colleagues in the world of Life Coaching.

Being endlessly fascinated by people, I love to see others’ sites and see what

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

they’re doing, what they’re offering, and learn of new ideas, take on challenging ideas… even see what I might be doing wrong. I am but human…

But some of these Life Coaches’ sites are just like an Internet hypermarket… What EXACTLY are they offering? I’ve no idea…

The idea of giving out free offers seems to have wreaked havoc with many! Tabs for

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

DVDs, navigation points for audio, books. A shop… is there homemade jam. A pie or two even?! One might only delve further into all the offers assaulting you the senses.

There are so many offers – for downloads, for audio products, DVDs, seminars… then free this, free that… plus more reports available for purchase than a provincial library, even a

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

college library, might have space for. There are offers promising links to yet more offers. Once there you’re whisked off to a more distant page, even another site… Suffering from cyber jetlag and inundated with promises of world shaking authority, free reports for life, downloads to ferry you well into the next life... and keep you amused when the

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

re.

I love some of the truly great offers that people give: they can be wonderful. But speaking as an insider, I can say how many people are actively seeking to bombarde the viewer (or prospect) with these offers… to get them to pull out their credit card and get buying… BUY! BUY! BUY! And you’re saved! Order now, and be saved before the bill come

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

in! Buy NOW! Order this… save your life… etc… etc. Stuff the coaching - Just get buying! You’ll be saved… your dilemmas met! (Or is it coaches who may be saved, having generated a decent stream of income… forget the coaching… they don’t really DO that anyway!)

I’ve felt so dizzy, overwhelmed and stunned by some sites of so-called world leading g

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

Following aspects would a

rus that I’ve hit exit, unable to endure my heart’s palpitations, trembling at the literal deluge of information that might (that WILL!) assault my room should I accidentally be terrorised enough to hit the “download” key in error - or by intimidation – and give the printer the OK to get churning out endless pages! (At least I could wallpaper the l

dd to the challenges in developing combination products:

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

o with something to keep people reading I suppose…)

But what is it they are offering? Coaching? Great advice? A wish to HELP me? Or can it really be just a sneaky way to get money to hook me and line in a stream of money Who knows.

And where IS the coaching bit?

I’ve got to say I’ve been to sites and been almost UNABLE to find out anything

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

about the services they offer that are really to do with coaching and helping people address and get on top of their life changes. But, of course, I can’t say who they are… I don’t want to be sued. But isn’t doing coaching what coaches are supposed to do?!

My point is that some of us – with albeit massively less vibrant and gyrating websites – are

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

genuinely out there wanting and trying to offer people decent, excellent help and service. We can do it - and we can do it brilliantly. We can’t do magic websites though…! But do we really want to?

Another ever growing b?te-noire of mine?

Newsletters…

All coaches are doing them now. I would if I could get my web designer to do me the ne

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

essary technology… and I’ve asked!

I’ve no problem with newsletters per se. I receive a varied selection of them from colleagues on both sides of the Atlantic. A couple are just great! Short, pithy and delivering a big injection of enthusiasm, motivation and energy! Like a morning shot of espresso. Delicious and a tonic.

But… heavens!!! Some of t

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

Professional from academic institutions, pharmaceutical industries, health care indust

em….. run into pages and pages of “stuff” … I can’t advise as to the quality therein – I’ve never read them: I’ve simply never even bothered! Why would I… I feel swamped and buried in glue the second my eyes confront an endless scrolling down of paragraph after paragraph of stuff! STUFF by the page load!

And some of them are so dull looking too! U

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

nbelievable with all the technology, creative possibilities, fonts and colours at our fingertips on computers… Don’t even mention typos, poor grammar or muffs… Does anyone wade his or her way through these epistles of self-glorification? Some of these coaches seem to have given themselves such elevated status I feel them convinced they are The Mes

.

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

iah of modern times. The Guru of Life… or should they just get a mirror and talk to themselves.

We all love a good bit of stimulation, and I’m sure there are many great points in many of these tomes of “wisdom” (which is often subjective anyway…) … but what’s happened to the “service” they’re supposed to be offering… LIFE COACHING?

Hmmmmmmmmm… I’

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

Companies that provide selfless information through particip

ranting… and the pages are filling up!

But smile! I’m on your side… I want to help people do their thing better and with ever greater ease and facility. I definitely don’t want to be stuck writing a load of waffle all day long!

Think about it!

But not too much… go and have some fun! Much more important… and it’ll be much more beneficial

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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If you are a sales person and problem solver you need to be schooled in the art of telling stories instead of telling people to buy what you are selling. People get rather tired of the same old lines and human like analogies and stories, it appears to be how our minds think these days.

Once you find your dream car, you will have to figure out how you can afford it. There are many financing options available, of which the new car loan is the most feasible.

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