Your Space - Health and Fitness

For the purpose of this article imagine yourself being unwell. Think of waking with a severe sore throat, lots of large neck glands and feeling pretty ropey. Would you go to

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

your doctor? If not what else might make you go? What questions do you ask yourself?

Let us go through some of your possible questions and answers:

1. What has happened? I

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

Examples of combination products may in

t's probably just a virus, Max had it last week.

2. Why has it happened? I've been working late, a bit overtired, resistance a bit low.

3. Why to me? Rotten luck but I alway

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

get these things, Max sneezed over me.

4. What should I do about it? Dose myself up with soluble aspirin and it should just go.

5. Is it serious? No it will be gone in a fe

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

w days.

But what happens if the exams are two weeks away or there is a hockey trip to California next week?

1. What has happened? Maybe it is a streptococcus?
4. What s

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

Combination pro

ould I do about it? I better see the doctor for some penicillin.
5. Is it serious? Yes if I fail the exam or if I can't make it to California.

Or what if your partner ha

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

s glandular fever.

1. What has happened? Oh god it's glandular fever.
2. Why has it happened? Too much kissing.
3. Why to me? I had it coming, life has been too goo

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

recently.
4. What should I do about it? I had better see the Doc to do a monospot to confirm it.
5. Is it serious? Yes this could put me out for the rest of the yea

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

r, I have also read it can cause Hodgkin's disease, oh my God!

These questions and answers can be translated into the trinity of ideas, concerns and expectations. To continu

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

with the same example of the sore throat and glands scenario think of:

What ideas might be going through your head that first morning...... "I feel awful, really really bad,

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

too bad for a cold, it must be at the very least flu. I bet I got it from Max he was coughing and sneezing all over me last week. It might be streptococcal so a trip to the d

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

Following aspects would a

octor for some penicillin might help. I wonder if there is any left in the drawer that I didn’t take last time? I will have to get some soluble aspirin"........etc

What conce

dd to the challenges in developing combination products:

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

ns might be wandering through your brain? "Help, I hope and pray it's not glandular fever. If it is that's the exams down the tubes, and it can lead to Hodgkin’s can't it? Wha

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

t if it's worse? I mean acute leukaemia can start like this. I have been worrying about my immune system for some time. I haven't caught AIDS from that dirty toilet seat have

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

? Don't be silly but it could turn into quinsy I think they call it, like that poor bloke in the other office last week. His tonsils were so big he couldn't breath. If I don't

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

get this fixed pretty quickly next week's trip to California with the hockey team is finito." etc

What about your expectations?......"If I do nothing it will probably go awa

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

Professional from academic institutions, pharmaceutical industries, health care indust

if I dose myself up, but penicillin is a good idea because it might speed things up especially with the hockey trip coming up. I expect the old Doc will just tell me it's a

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

virus and I will have to lay it on a bit thick to get the penicillin. He might do a blood test for glandular fever. Shall I tell him I am a bit worried about AIDS? No he will

.

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

hink I am silly. I expect he will tell me off for smoking too." etc

This leaves us with a very important truth:

None of us goes to a Doctor with just a symptom.

• We go wit

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

Companies that provide selfless information through particip

h IDEAS about the symptom,
• with CONCERNS about the symptom and
• with EXPECTATIONS related to the symptom.

I will expand on these three givens in later articles

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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