References - Travel and Leisure

Some people pack for a trip by chaotically tossing everything

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

(and anything) into a suitcase.

Packing for a trip then bec

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

Examples of combination products may in

omes a frantic, stressful activity often resulting in surpris

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

es (such as when you forget something).

Simplify packing by

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

aking a check list of everything that you need. If appropriat

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

Combination pro

e, prepare different versions of this list for different type

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 of travel (such as, business, informal, vacation, conferenc

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

e, international, and so on). Organize these lists by groupin

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

similar types of items, such as underwear, accessories, toil

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

etries, and so on.

Save these lists as the first column of a

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

table or of a spreadsheet, so it can be used several times.

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

Following aspects would a

Now, packing becomes a scavenger hunt to collect the things

dd to the challenges in developing combination products:

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

n the list.

Then check off each item as you put it in your s

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

uitcase.

This helps you save time in the following ways:

*

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

It makes packing more efficient. I’ve found that packing take

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

s half as long with a check list compared to without one.

*

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

Professional from academic institutions, pharmaceutical industries, health care indust

ou will remember everything that you need.

* Preparing the l

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

ist helps plan what to take. As a result, you will pack only

.

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

what you need for a trip.

* Packing only what you need saves

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

Companies that provide selfless information through particip

time when you unpack since you have fewer things to put away

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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References - Use a Check List to Save Time Packing

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