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You never know what you’ll get and sometimes what you get is not what you expected.

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

But you always start the same way… First, you screen out the ones that are obvious

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

Examples of combination products may in

ly not good. Second, you look at the remaining ones and you pick a few. Third, you

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

give it a try.

There are some basic lessons to learn from the above analogy. Form

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

matters because it is the first thing recruiters will set their eyes on. In order

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

Combination pro

to pass the first stage, an application has to be appealing and look professional.

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

Once the preliminary screening is done, recruiters go to the next stage of looking a

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

the substance of the applications. If they like dark chocolate, they will choose t

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

hem first. Too bad if you are vanilla! Concretely, this means that you have to mee

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

t the employer’s requirements.

Last step can be either the most rewarding one or th

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

e most disappointing one. You taste the chocolate with high expectations since you

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

Following aspects would a

think you did a good job screening out what you don’t like. Some may be up to your

dd to the challenges in developing combination products:

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

expectations, some less, some not at all…

What is the lesson from all this? Writin

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

g good resumes or cover letters can help you get to the third stage, but if you don’

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

have what the employer really wants, you won’t get in… and you might get burnt at 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

he interview. Alternatively, if you have what it takes, but cannot make your case,

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

Professional from academic institutions, pharmaceutical industries, health care indust

too bad, you just missed the boat! This doesn’t mean that you have to be modest. I

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

t simply means that you have to look at the application process as a whole and be ho

.

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

nest with yourself and the recruiter.

Whatever you write in your application, be su

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

Companies that provide selfless information through particip

re you can back it up at the interview. Playing up expectations doesn’t always help

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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