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Picture the scene. Anthony pops down to the guardhouse, partly because he wants a break with the lads, but also because he has a problem. Cleopatra says she wants to bathe in ass's

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

milk. So Anthony tells the guys in the guardhouse, that he needs some help. "The wife wants to bathe in ass's milk now." He says.

Gerald, the Head Guard, says, "She wants to what

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

Examples of combination products may in

?" "Bathe in ass's milk", says Anthony, "You know what these women are like - she's read it on some tablets of stone somewhere - it's supposed to be good for her complexion".

"So h

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

ow are you going to sort that out then," says Gerald, "Are you going to get someone to pour it over her or something?" Anthony thinks about it and says, "No, that won't do, she want

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

s to soak in it. She needs a 'bath'."

"What's a 'bath' then..", says the Gerald. "It's a big thing you get into that's full of the ass's milk - and then you lie down in it," says A

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

Combination pro

nthony.

"What do you want to do that for then..?" asks one of the new guards, a young lad really.

"So you can get clean all over and relax in it - let the ass's milk do it's job."

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

Says Anthony, trying to sound as if it makes sense. "Oh, right then.." Says the Head Guard.

"Nah, I don't know where you'll get one of them."

Anthony goes on his way, this time s

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

topping at the stonemason's yard, thinking all of a sudden, those big stones we shape, all we need to do is to hollow on out and that will do.

So he starts a conversation with the

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

Head Stonemason, Steve. "Can you do me a 'bath'", he says. "What's one of them, then?", the rather busy stonemason says. "It's a big thing you get into and lie in, full of hot liq

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

uid. It's relaxing." Anthony says, sounding less and less convincing each time. "You can do it, with this stuff you're cutting up each day, it'll be a breeze". "Nah, mate," says Ste

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

ve, "This stuff is sandstone, it won't hold the liquid".

Disappointed, but losing a bit of interest, Anthony moves along in his quest.

But it starts the stonemason thinking - he h

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

Following aspects would a

as a bit of spare granite out the back of the shed, so over the next few days, he does a bit if chiselling and sees what he can do.

A week the following Friday, he gives old Anthon

dd to the challenges in developing combination products:

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

y a shout and shows him his work. "Brilliant", says Anthony - let's get it installed, she'll be having her nails done all afternoon. "Let's get those asses milked too", he shouts to

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

his PA.

Later that afternoon, Cleopatra has a big surprise and excitedly clambers into the new granite bath, filled with warm asses milk and she is in seventh heaven.

Bet you're

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

wondering what the moral of the story is eh?

Well, in our everyday job, we are faced with dozens of little challenges. New problems to puzzle out. And they cause us irritation and

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

frustration. Yet, like the stone mason, Steve, we have people around us who, left to their own devices and interested enough in the challenge, will sort things out - in their own wa

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

Professional from academic institutions, pharmaceutical industries, health care indust

y and in their own time.

It's as true today as it was when Anthony and Cleopatra were around.

There is a postscript to this. Two days later the stonemason is called up to the new

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

'bath' room. Cleopatra was pleased to see him and thanked him for his excellent work but asked, discreetly, if he could bring his polishing stone up with him later.

"The bath is

.

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

great, but I have a little problem. There's something right in the bottom corner that is a little rough - in fact, she said, it's a bit of a pain in the ass."

Knowingly, the stonem

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

Companies that provide selfless information through particip

ason left the bathroom for his tools. "I know, I know" he said, "We get them all the time." And he smiled a little smile as he prepared to meet a challenge of a more delicate nature

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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