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Nobody wants to be caught with his pants down. Aside from the great inconvenience, you will be put in a very awkw

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

ard position and you’ll have a tough time making a rebound. So how do you keep those pants on?

A key factor in e

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

Examples of combination products may in

very successful undertaking is a sound plan. Making an outline of the steps to be taken as well as preparing for

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

contingencies if things go awry is very important. You can’t possibly play basketball without a ball, right? With

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

ut having planned the game, you must have ASSUMED that someone have brought that ball. No plan has been made and

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

Combination pro

no coordination took place and that is why we simply assumed and we know that assumptions are one big killer of s

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

uccess. Instead of hearing, “I thought…” it would have been very good to hear “I’m sure.” And just what on earth

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

as this got to do with printing?

Like everything else, a successful print venture benefits from good planning. B

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

asic to your printing success is a good understanding of what it is that you want, what you need to get that goal

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

and making a follow-through. An efficient starter would be making a preparation of all the materials, know-how

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

nd the manpower needed for the task. All of these of course will have to take into consideration the available bu

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

Following aspects would a

dget allotted. Gathering the materials in advance is a surefire way to cut costs because this will prevent you fr

dd to the challenges in developing combination products:

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

om making rush orders which are usually astronomically priced. Also, learn in advance the processes and technique

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

s that will be used in your printing endeavor. Making a trial-and-error approach here is not only unwise but cost

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

y. The needed manpower pool should be ready by now and have been informed what to do. You must have communicated

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

with them what is your goal and how to reach it. Make sure, do not ASSUME, that you have been understood for this

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

Professional from academic institutions, pharmaceutical industries, health care indust

will make the work flow smoother and will save time and money plus this will spare you from headaches. Typical e

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

rors committed are because of these unnecessary assumptions.

The keywords to remember here are PLANNING and COMM

.

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

UNICATION and that presumptions should not be made or else there will be trouble. Think long-term and make sound

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

Companies that provide selfless information through particip

plans and you can be sure to reap the benefits of what you have sown. And that my friend, will keep your pants on

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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