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You know that it's important to check references before asking a new roommate to move in, but are you confused where to start? Checking the references of

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

your chosen roommate is similar to checking references when a person is hired for a job. It lets you confirm that you have chosen the perfect roommate for

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

Examples of combination products may in

you or alternatively, lets you find any hidden surprises before it's too late.

The process of checking references starts as soon as you ask for referenc

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

es from potential roommates. Ideally, you should ask for 1-2 references during the roommate interview and ask to speak to former roommates. Previous roomm

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

ates can give you the best idea how it would be like to live with your chosen roommate. If they are unable to give you references from previous roommates,

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

Combination pro

you may wish to ask why they are no longer in touch with them.

If you're unable to speak to any former roommates, ask for references from friends and fam

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

ily. They can often given you a good insight into your selected roommate's personality and living habits. For example, your chosen roommate's brother or s

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

ister may tell you that they always have an untidy bedroom. You can compare this answer to your selected roommate's answer and decide if they are still th

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

e roommate for you.

When you talk to the referees given to you by your chosen roommate, you should start by verifying basic important information. This m

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

eans you need to confirm the:

1. referee has been a roommate of your chosen roommate
2. number of roommates living in the household
3. dates

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

he roommate lived at the address
4. reason your selected roommate no longer lives in the household

Once you have verified these basic facts, y

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

Following aspects would a

our next step is to find out about the referee's experience of living with your chosen roommate by asking relevant questions. It's important to be aware t

dd to the challenges in developing combination products:

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

hat the referee may give you biased information but by asking the right questions you should be able to sort out fact from fiction.

The key is to ask que

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

stions that let you find out factual and objective information about how it would be like to live with your chosen roommate. It's a good idea to decide wh

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

ich questions you would like to ask before you speak to each referee. Here are some sample questions.

1. How long did you live with this roommate?

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

. Why do you no longer live with this roommate?
3. Would you live with this roommate again? Why?
4. What are the 3 worst habits of this roomma

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

Professional from academic institutions, pharmaceutical industries, health care indust

te?
5. What did you enjoy about living with this roommate?
6. Did the roommate pay the agreed rent and expenses on time?
7. Did this roo

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

mmate cause any problems while living with you or other roommates?

You may need to ask some tough questions because after all, you'll be the one that

.

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

will be living with your chosen roommate. Just remember, checking references is an important part of finding your perfect roommate. By checking roommate

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

Companies that provide selfless information through particip

references through asking a few simple questions, you'll soon be on your way to choosing the right roommate for you.

Good Luck and Happy Roommate Hunting

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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