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To preface, I look at the review process one goes through when analyzing anything as working on a bell curve. For those not familiar with it, a bell curve has a single high point where maximum efficiency is

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

reached. Before that high point, your efficiency in whatever you are doing is increasing. After that high point, your efficiency is decreasing. With this in mind, we can move on to the purpose of this arti

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

Examples of combination products may in

le.

When conducting a review, it is very easy to fall into the trap of Over Reviewing. This can also be seen as where you are working on the wrong side of the bell curve, or after the high

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

oint of efficiency. Basically, you have gotten to a point where further review is not only unnecessary, but it's actually detrimental to the final product.

Now, I know that the common belief is that you can

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

never spend too much time reviewing. However, I would like to make an addendum to this: You can never spend too much time reviewing as long as you have not reached your review high point.

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

Combination pro

The hardest part of reviewing something is not the review itself, but knowing when you have reached this high point. Unfortunately, until you've had some experience, you might not know that you've hit your h

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

gh point until you start to slide down the other side of the curve. However, here are a few ways that you can tell it's time to put up the red pen:

Your Deadline is impacted - Thi

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

s is a major sign that you have spent too much time on the review. When your deadline for the final product starts to slip because you are still in the review process, or you took too long reviewing, then mo

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

t likely you should have stopped reviewing already. Now, this may not be true all the time. For example, if the product you were given to review was awful to begin with, that might mean that you need more r

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

view time than was originally budgeted. Also, if you initially under-budgeted your review time, then this could be a cause as well. However, I find that most of the time the problem is that you don't know w

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

en to stop. If you set aside a period of time for review and find yourself coming close to going over it, you need to re-evaluate how much time you are spending on review.

Your changes are

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

Following aspects would a

causing problems - This is one is tough because it is really a judgment call. First off, when you change anything, you have to be aware that there could be other problems caused by this change. Fo

dd to the challenges in developing combination products:

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

example, if you change the size of a table in a document, you should know that this could change the layout of the other pages in your document. When you start spending too much time on your review, you wil

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

notice that minor changes are causing more problems than they are worth. Using the table example, say you want to make the one row on a table slightly smaller to match the other rows. However, by doing thi

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

s you are going to change the page layouts of all of pages following this table. Should you do it? Your answer should be no. I'm not saying you should never make a change that causes other problems (someti

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

es you need to), what I'm saying is that if you are running into this a lot, it probably means you are over-reviewing.

Your other work suffers - Pretty obvious one here. If your oth

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

Professional from academic institutions, pharmaceutical industries, health care indust

r tasks suffer from lack of attention, then you are probably spending too much time on this one task. Most of the time you will have more than one thing to work on. While your time should be budgeted for ea

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

ch task accordingly, if you exceed this budget the time you use has to come from somewhere. There are only so many hours in any given day where you can effectively get work done. If your current review genu

.

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

nely needs more time, then so be it. But make this decision carefully, and make sure to take into account the time the rest of your tasks need.

In the end, only you can decide on how much time y

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

Companies that provide selfless information through particip

u spend reviewing something. However, if you keep the above points in mind when doing so, I think you'll see an increase in both the quality of the finished product and the quality of your other work as well

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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A riff on giving and getting a good service, both on and offline. Will the future regard the online services kindly or harshly? It is not that safe in the offline world anyway.

Having been involved in business and politics and watched government attack us business folk and thus having been on all sides of this equation, it is readily apparent to me that the humans are just doing what humans do anyway.

Metal working is an old and skilled industry - primitive man first discovered the importance of metal working and the Romans and Egyptians were both skilled in it. Like many other industries, it relies heavily on lubricants to help keep things operating smoothly. Today the metal working lubricant market accounts for around 5% of the total lubricant market.

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