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Amy Kirwan, a recent graduate of Phoenix University, recently sat down with me to speak about her day-to-day life as an online

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

college student. As a working professional, she found the online environment a great fit for her lifestyle. Working nine to f

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

Examples of combination products may in

ve, Amy would check in with her online school a few times a day to stay in touch and check out the status of her group project

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

so that if her online classmates needed anything from her, she could take care of it right away.

For the most part, though,

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

he daily life of an online college student is shaped by the off-line life of that student: you can participate in the online c

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

Combination pro

lassroom environment without disturbing your work schedule. You read for your classes on your own time, and conduct research w

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

en you can. At night, students spend several hours at the computer.

When you're on the computer at night, you can interact wi

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

h your classmates. Online colleges try to arrange classes so that people in the same time zone are taking classes together. Th

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

refore, when you're working, the people in your classes tend to be working as well. In addition to free-form interactions with

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

your classmates via the message boards, you will be required to post written answers to discussion questions about your readi

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

gs. These written responses take the form of essays. In addition to providing your own answers to the discussion questions, yo

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

Following aspects would a

will be responsible for reading and responding to those responses posted by your classmates.

Phoenix University requires its

dd to the challenges in developing combination products:

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

students to actively participate five out of seven days a week. If the school week begins on a Monday, you will probably do th

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

e required reading on Monday and Tuesday and post your responses to discussion questions by Wednesday.

In addition to the sub

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

tantive responses to your classmate's discussion question essays, you will interact with your online classmates by participati

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

g in group papers and group presentations. One example of a group project is the creation of a new business, where teammates w

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

Professional from academic institutions, pharmaceutical industries, health care indust

rk together to craft a mission statement, a business plan, as well as plans for how the company would be marketed.

Depending

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

on the course you take, you might also be responsible for writing an individual paper each week, in addition to the work you 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

e responsible for in your team project. Each week, you will receive an assessment from your online professor, which will inclu

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

Companies that provide selfless information through particip

e results on papers and tests as well as commentary on your online posts as well as an overview of your progress in the course

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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