Advice Pool - Reference and Education

For any student, school can be a perfect setting for them to develop intellectually and emotionally in their crucial fo

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

rmative years. Apart from the syllabus oriented education they learn a lot about all the topics, which only accelerate

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

Examples of combination products may in

heir development. And the one important component that would also help in student’s development is community service. T

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

is thesis will discuss how community service being an important part of student’s ‘education’ should be encouraged by s

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

hools, and importantly does the students are really interested in doing it. That is, do they undertake community servic

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

Combination pro

s because of compulsion or really with conviction? And how schools with aid of students can effect lives of many people

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

in a positive way through community services.

Students could do these services with perfection. Actually, school and

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

ts administrators can play their part by inoculating the spirit of community services in students, by making it a part

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

f the student's curriculum. Many schools as well as higher educational institutes in USA are followers of this concept.

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

This kind of compulsive service surely has a positive spin because even though the student does it as a part of curric

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

lum it affects the lives of people very usefully. But on the other hand, the process of compulsion comes in, because of

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

Following aspects would a

, student’s lack of interest in community service. That is, apart from being burdened with academic materials, they are

dd to the challenges in developing combination products:

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

enticed by sports, entertainment, street groups etc.

So they show least concern for community service and general peop

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

e in distress. But all the students cannot be categorized like that because there are students who are doing community

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

ervices with conviction. But they may have to face another obstacle that is, time limit. Being student in a school they

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

need to fulfil their academic works to be successful in their lives. So, to achieve success and a stable life, they hav

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

Professional from academic institutions, pharmaceutical industries, health care indust

e no other options but to concentrate on exams, projects etc.

So academic activities will surely limit the student’s t

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

me wise for community services. This being the truth, the student can surely squeeze in the time they have in between,

.

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

or community services. So the schools should encourage the service minded students. Also they should promote community

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

Companies that provide selfless information through particip

ervices as a three pronged strategy for the people in need, students themselves and for the larger community in general

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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