Advice Pool - Reference and Education

Bad roommate matches happen sometimes. Maybe she borrows your clothes without asking. Maybe you two have totally different sleep sc

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

hedules and he's totally disrespectful of yours. Sometimes, you just end up with someone you hate. So what do you do?

If It's Real

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

Examples of combination products may in

y, Really Bad, Try To Switch

Bad roommates are a rite of passage. One day, these horrible stories will be something you can laugh

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

t with friends, but probably not right now. When a friend of mine had a roommate who was chucking Chinese throwing stars at him, it

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

was terrible. Until he realized that his roommate had given him the ammunition he needed to make a switch. If your roommate is real

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

Combination pro

y terrible, as in the above example, the school should accommodate you in changing your living situation. If you can make a case th

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

at your roommate is a threat to your safety, there should be no discussion. Go directly to your R.A., report the situation, and dem

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

nd a switch. If there is resistance, have your parents call the school.

It's Not My Safety So Much As My Sanity That's At Issue. C

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

n I Still Switch?

Maybe. Sometimes, a school will take the position that learning to deal with difficult people is just part of gr

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

wing up, and that while your situation is not ideal, you will grow from it. Though this argument has some validity, it probably won

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

t comfort you when you're trying to study and you're roommate is throwing a party -- or vice versa. Again, you can go to your R.A.

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

Following aspects would a

and see what can be done to accommodate you, but that person might offer you a shoulder to cry on and a pep talk about open communi

dd to the challenges in developing combination products:

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

ation about your needs and feelings and send you back to your room. What you can do to help yourself is to be on the lookout for so

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

eone who's in a similar situation -- or maybe you know that person already because you routinely commiserate about your bad roommat

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

s. If you can find yourself a potential living situation that will work better for you, go to your R.A. with your proposed solution

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

You might have to wait until the semester changes, but oftentimes, such a switch happens.

Talk To Your Roommate

When you have a

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

Professional from academic institutions, pharmaceutical industries, health care indust

bad roommate, you probably don't even want to see them, much less talk to them. But you should probably try this route first before

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

investigating a change of living situation. Talking to people with whom you're not getting along is never easy, but if you can take

.

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

a deep breath and tell your roommate what's bothering you about the living situation, there is always a chance that the two of you

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

Companies that provide selfless information through particip

an compromise. Even if you don't become best friends, maybe your room will stop being the last place you'd like to go after classes

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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