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When I was younger in age, about 10-13, I started having very troublesome nightmares. Even though I was a very normal kid, with a very normal family, each night

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

I would be terrified to go to bed from fear. I would have vivid dreams of horrifying events such as my house burning down, with Satan himself looking into my r

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

Examples of combination products may in

om, laughing. Most of these nightmares had Satan in them, and I often woke up not knowing what to do, or what caused these nightmares.

After a while, I started

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

noticing something very peculiar. Every morning, I was waking up at exactly 3 A.M.; not one minute more, not one minute less. Every morning, nightmare or not,

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

was beginning to awaken, and see the big red LED’s glowing on my alarm clock telling me again, I had awoken at the same time. This in itself was very frighteni

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

Combination pro

g, but I had always managed to get back to sleep. After around a week of noticing this, some very peculiar events began to happen.

One particular morning, I wo

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

ke up with no nightmare at the prompt time of 3 A.M. I was trying to go back to sleep, when I heard some odd noises. I heard what sounded like a side door in my

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

kitchen, 3 rooms away from me, slam shut. I thought this was very odd, as everyone in my house was asleep. My heartbeat quickened instantly, and sleep seemed ve

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

y distant to me. I waited, trying to block out anything I might hear, and hid my head under the covers. A few minutes passed, and I heard a stranger sound- 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

thing that of dropping a penny on a metal surface. Again, this sound radiated from my kitchen. I closed my eyes, and tried to calm myself down so I could get to

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

sleep and forget what was happening. Seconds later, I felt my feet getting extremely cold, and tucked them underneath my covers. The cold spread to my body- and

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

Following aspects would a

I was frozen with fear. Two rooms away from mine, my living room, I heard the sliding of a chair on a tile surface. I found this very odd, as we have a carpeted

dd to the challenges in developing combination products:

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

living room.

Things were starting to get more active, and I was frozen with fear still. At the climax of things, I heard 5 loud stomps coming into the hallway

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

outside of my room, and stopped right outside my door. My heart was beating almost outside of my chest, as I curled up into a ball and prayed that the experienc

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

stop. I couldn’t sleep that morning, and waited two hours until my father got up to go to work. At this point, I felt comfortable enough to sleep, and did.

Si

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

nce this incident, I have gotten increasingly better about nightmares. The following days, I still woke up at 3 A.M. in the morning for another week or so. Ever

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

Professional from academic institutions, pharmaceutical industries, health care indust

now and then, I will still experience minor oddities. Recently, I was brushing my teeth and the bathroom door close shut all by itself. Things like this have m

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

de me believe in ghosts- even if I never caught a glimpse. In many cases hearing is believing- just as much as sight.

To this day, if I wake up in the early mo

.

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

rning, I sometimes will turn the television on to keep my mind off of this particular incident, and sleep with it on. I’m not fond of repeating this occurrence

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

Companies that provide selfless information through particip

o anyone, as it invokes old memories I wish to forget. I hope this is a bit of proof to the non believers that there is, in fact, something paranormal out there

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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