References - Self Improvement

I’m sure we’ve all had the experience of having a certain block of time available, and our to-do list tasks or goals that we want to accomplish in tha

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

t time frame, only to turn around at the end of that period of time to have the frustrating experience of not getting nearly enough done that we thoug

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

Examples of combination products may in

ht we could. What happened? Where did all the time go? This can be in our personal / family lives, our jobs or our businesses.

Many of the frustra

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

tions of this are due to our expectations of what we can accomplish in that amount of time too high, and unrealistic. When we can look at it more obj

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

ectively, it can reduce stress in our lives, and give more of a sense of accomplishment when we do reach our goals.

Say you have 6 hours available to

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

Combination pro

do a certain project. Prioritize the tasks you want to tackle, with number one being the top priority. Now figure in your typical day, what percent

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

age of that time is typically going to “putting out fires” If approximately 1/3 of your time is this type of work / situation, deduct that amount of t

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

ime and your original 6 hours minus 2 hours of putting out fires, will give you 4 working hours.

Now, consider the average interruption will take abo

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

ut 8 minutes to deal with before mentally you’re back where you were before the interruption. How many interruptions are typical in your day? Let’s

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

say you get 10 interruptions, 80 minutes. Now subtract those 80 minutes from your 4 hours, now you’ve got a little over 2 hours left to try to accomp

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

ish what you thought you actually had 6 hours to do. Is it any wonder why we didn’t get as much done as we had hoped? I believe this will reduce fru

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

Following aspects would a

stration just knowing this, and will allow us to plan our day with much more realistic goals. If something is added to our to-do list, then somethin

dd to the challenges in developing combination products:

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

g else must give to make room.

There are some things that can be done to help however. Just looking at this may help you pin point sources of time

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

wasters. Is there anything that can be done to minimize the need to “put out the fires”? Are there any types of preventative actions that can be tak

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

en to at least reduce it?

What about interruptions? Can a phone voice mail be used instead of answering the phone? Then when you do need to return

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

calls, do them as a group, one right after another. What about email? Do you have to respond to emails during this time frame? Again, try to lump l

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

Professional from academic institutions, pharmaceutical industries, health care indust

ike tasks together, when you do need to email, handle it all at once instead of the second they hit your inbox.

Then realize, what you thought was yo

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

ur 6 hours, in reality were perhaps a little over 2. Attack your to-do list with your highest priority, then give yourself a pat on the back for work

.

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

ing your best with those 2 hours you had, and that in reality, you did fill 6 hours, and perhaps have a better understanding of where it went. Knowi

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

Companies that provide selfless information through particip

ng this will help reduce the stress and frustration of trying to accomplish what may not be possible, and give your planning a more realistic approach

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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