Summary - Relationships

Organising a party can be a stressful affair, organising catering, venue, entertainments etc. coupled with the stress of formulating a strategy that will get all of yo

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

ur 'fashionably' late friends to the venue at roughly the same time is often more of a trial than we expect (I have cryptic little numbers marked in my address book ne

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

Examples of combination products may in

xt to certain names which allow me to keep tabs on roughly how late each friend is likely to be. Hence, if the party begins at 8 o'clock sharp, Rita gets told 7, Rick

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

7.30 and Pam, who is known for a certain excess enthusiasm, 8.15). Even with the best laid plans, you can still be reasonably sure that at any medium sized social even

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

t, a portion of your friends will show up late and drunk; another contingent will show up too early, proceed to empty the bar of house gin and be busy acting like foam

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

Combination pro

ing degenerates by the time your respectable aunt from Colchester arrives (on time) and still more will set out from their respective homes only to be distracted by sh

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

iny things, delayed by clueless minicab drivers, arrested, press-ganged into the navy or otherwise waylaid in fantastic and barely believable ways. Meanwhile the cater

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

ers 'forget' to provide a vegetarian option, the venue's lighting develops an unexpected fault leaving the party to continue by the light of candles and/or neon strip

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

lights and the band shows up minutes before the venue closes with a two stringed guitar and a dented sousaphone.

You can probably tell by now that I've organised some

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

'interesting' parties in the past but, kidding aside, the aforementioned stresses pale into insignificance when compared to the tortuous process of drawing up the gue

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

t list. Now, this doesn't seem like it ought to be the most stressful aspect of a social event or even in the top five, but start to factor in past and present relatio

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

Following aspects would a

nships between your friends and a can of worms (or more likely a bucket) starts to creak open. Of course, the easiest solution is to simply ignore all concerns of soci

dd to the challenges in developing combination products:

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

al politics and trust that your friends are mature enough to deal with things amongst themselves; if you do this, you're either extremely lucky or a fool!

Picture thi

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

s scenario: Jim and Jane, both good friends of yours, were seeing each other for two years; they split up four months ago because Jim experienced some 'commitment issu

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

es' over moving in with Jane. Jim is now going out with Jenny, who happened to be looking for a flat when they got together about a month ago. Jenny moved in with Jim

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

temporarily while she looked for a new place, and has been there ever since. Meanwhile Jane has started casually seeing John, another good friend who you've all known

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

Professional from academic institutions, pharmaceutical industries, health care indust

for years. Jane has 'issues' with Jim, and has quite publicly expressed her desire to scratch Jenny's eyes out with a rake. Jim resents the fact that his old friend Jo

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

hn is dating his former lover and John is thoroughly bemused by the whole affair.

Now, I don't know about you but my head's spinning just looking at that last paragra

.

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

ph, and the last thing I feel like doing is worrying about whether to invite Jim and Jenny, Jane and John, Jenny and John or just invite all four in the vain hope that

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

Companies that provide selfless information through particip

they'll somehow sort it in civil fashion amongst themselves (yeah, right!). And so, dear reader, I shall leave you to sort out this mess. Answers on a postcard please

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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