Advice Pool - Reference and Education

Emma could not believe her luck. She walked into the kitchen, and it was spotless. The coun

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

ter was free of her housemates’ dirty, grimy dishes. The oven was sparkling clean, a pristi

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

Examples of combination products may in

ne white. And there was Brad, clad in only sweatpants, flipping blueberry pancakes in one p

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

an, and making eggs in another. The aroma of coffee, baking, eggs, and something… else fill

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

ed the sunny kitchen.

Brad handed her a full mug of coffee. “I made breakfast. I h

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

Combination pro

pe you don’t mind.” He winked at her.

“Mind?! This is unbelievable. I must be dr

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

eaming.”

And that’s when it dawned on her.

Emma woke up with a vague f

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

eeling of regret, but mostly, she was satisfied, feeling content. Some might have written i

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

t off as ‘only’ a dream. Emma preferred to focus on the fact that it happened at all.

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

>
The exact nature of dreams is still unknown. It’s not entirely clear what dreams “ar

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

.” It is known and it is clear that when we dream, our brains act as if we’re awake. One th

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

Following aspects would a

eory is that dreams are a way for our subconscious to work out the things we have to deal w

dd to the challenges in developing combination products:

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

ith but ignore during the day. But when we’re asleep and dreaming, our subconscious is free

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

to play with whatever is lurking around.

But Emma hasn’t been dreaming. She had b

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

een fighting with her with her 3 housemates over petty, inane things. She’s been stressed,

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

rinking too much. She’s been sleeping in a messy room on sheets that haven’t been washed fo

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

Professional from academic institutions, pharmaceutical industries, health care indust

r over a month.

Without dreams, her subconscious hasn’t been able to reinterpret

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

things, or present them in a new way, in a way that might give let Emma see her issues in a

.

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

different light. She hasn’t had any distractions from her stress. That was before last nigh

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

Companies that provide selfless information through particip

t. Last night was different. Emma cleaned her room. She washed her sheets. And she dreamt

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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Advice Pool - The Importance of Dreaming

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