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In modern society passing educational examinations becomes an increasingly important and essential means to a better job and improved living standards.

The structure and nature of all examinations are things we cannot chang

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

e to suit ourselves. Hence we need to find ways of dealing effectively with them - ways of making their systems and requirements actually work for us.

There are ways of doing this and the following can be successfully used

; 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 anyone studying for any examinations because exams usually have certain key common elements.

Check Out The Syllabus As an examinee, you have to abide by certain rules and constraints. The time length of the exam, how many qu

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

estion you have to answer, and so forth.

But the examiners also have to abide by certain rules - and they cannot change them (at least not without adequate notice) any more than you can! They have to publish a syllabus for

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

very examination and they can only ask questions on what is contained within that syllabus. Once you know the syllabus, you know where the starting and finishing lines are and how far you have to run

Moreover, all parts of t

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

Combination pro

e syllabus are not equal: some parts of it are more equal than others. Some topics will hardly ever be questioned while others will come up every year. Highlight the syllabus using two colours: red, say, for those areas that

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

come up very frequently; green for those which rarely come up. Do this only after a systematic inspection of past exam papers, as the next section will explain.

Then use a third colour to highlight those (hopefully very few) p

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

rts of the syllabus which you have really serious difficulty with. Providing these parts are not numerous, and depending on how often they come up, it may be possible to leave them on one side. But do use sense and judgement i

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

n doing this!

Whatever You Are Studying, First Study The Exam Papers Studying past examination papers is almost as crucial as studying the subject you have chosen!

Get hold of as many past papers as you can. The more you hav

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

the better you will be able to discern any patterns. Draw up a grid on A4 paper. Divide the top horizontally into years - as many as you have past papers for plus one for the year in which you are going to sit the exam

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

Divide the lefthand vertical into as many subject areas as seems appropriate from your inspection of the syllabus and past exam papers. Do this very careful and only after you have become very familiar with the exam topics. Al

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

Following aspects would a

so, make allowance for any coupling of topics because sometimes examiners like to link one topic with another. If you have, say, a dozen past papers and a particular linking has only come up once, you are probably save to forg

dd to the challenges in developing combination products:

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

t it. But if it has occurred, say, three or four times it needs to go down.

So now you have large set of cells, each of which relates to a particular year and to a specific topic. Place a cross in each cell for the year in whi

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

ch a given topic has come up. If there is a pattern, and very often there is, you will soon see it. The relative frequency with which the various topic come up will now be easy to see.

It is not that examiners are doing a par

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

llel kind of exercise to determine the structure of the next examination they set. They might well be unaware of the kinds of patterns we are talking about. But examiners do have at least a mental scheduling of the relative im

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

ortance of particular topics and an impression of what have been chosen recently.

Now use the spare column on the right-hand side, which relates to the year you are going to sit the exam, to mark those subject areas which see

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

Professional from academic institutions, pharmaceutical industries, health care indust

m most likely to come up this next time. These are the ones which you need to spend extra time on. The other areas need to be covered as well, but your projections need special care and attention.

In the case of some examinat

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

ons such a pattern may not seem to emerge. But often it will. In any case, it is worth the investment of time to find out, and whether it does or not it would be foolish not to inspect as many past papers as possible. You need

.

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

to see how the questions are phrased, how they are divided, sometimes even subdivided, whether there are any special conditions imposed, such as papers which are divided into different sections with different lengths of time

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

Companies that provide selfless information through particip

llowed for each, and so forth.

Overall, many students just seem to accept the constraints of an examination system as a barbed wire fence they can do nothing about. But the foregoing might just give you a set of wire cutters

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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The greatest RISK in marketing lies in dealing with OPINION instead of fact. Stated another way, risk and the threat of loss is rooted in the idea that you think you already know the answer. Do you feel you know the answers to your customers most pressing problems, or are you genuinely in communication with them and listening to what they say?

Who wants what you are selling? Sure, you may have what you think is a great product, but maybe not everyone would agree with you. The thing is that you need to find your target market. Watch for the latest trends and you may want to subscribe to a couple advertising/marketing magazines to see what other people have out there.

How to Make Money Fast and Easy. Three critical elements that you must have in place to make it happen.

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