Summary - Reference and Education

Everyone wishes that they could have a little more education in order to get that promotion, earn that extra dollar, or just show

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

off to your friends. The problem is many of us don’t have the time or the money to go through a 2 or 4 year college program.

The

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

Examples of combination products may in

ood news is that there is a way that you can essentially skip possibly a full year of college. Well maybe skip is a bit much as yo

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

will have to do some work but you will save a lot of time and even more money.

Most degrees or diplomas have first year courses

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

that are a lot more general then what you will take in the following years. These classes are also very similar to what you learne

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

Combination pro

in high school. If this is the case why should you have to sit through, and pay for, all this knowledge you already have. The goo

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

news is you don’t.

The CLEP Exams

The way that you can get skip these courses is by testing out of them with the CLEP ex

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

ams. Basically these exams allow you to take 1 test and if you pass it you will get credit for a full semester class. It sounds ea

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

y doesn’t it? Well it is in a lot of ways but there are a few factors you should know.

Details Of The CLEP Exam

The first

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 you should know is that although these exams are great they are not free. Usually each CLEP exam you take will cost aro

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

nd $55. However, depending on the college you are attending they sometimes charge an extra administrative fee. Even if this is the

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

Following aspects would a

case considering how much your courses cost this isn’t too bad.

The next thing you have to look out for is your college’s policy

dd to the challenges in developing combination products:

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

on CLEP exams. Many colleges accept only certain credits or some allow you to only test out of a certain amount of courses per sem

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

ster. On the other end some schools allow you to take as many CLEP exams as you want. Look on your college’s website or ask an adv

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

isor before you write the exam. The worst thing is to study and pass just to learn you can’t use the credit.

Studying For The

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

CLEP Exam

When it comes to studying for the CLEP exams your first stop should be to check out the

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

Professional from academic institutions, pharmaceutical industries, health care indust

www.collegeboard.com/student/testing/clep/about.html>www.collegeboard.com. This site has all the material that will be covered

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

on each exam. Once you’ve checked out that site you may also want to look at www.c

.

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

epinfo.com. This site has a lot of good information on the CLEP exam and they also provide reviews of different study guides.

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

Companies that provide selfless information through particip

ou should do your own research before picking a study guide as their are a lot of guides out there and not all of them are helpful

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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