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Everyone’s biggest problem with Writing Task is finishing both tasks on time. What no one tells you is that if you don’t finish either one, you l

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

ost a whole band point. This never has to happen to you!

The key to making sure that you report and essay qualify as finished is that they have

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

Examples of combination products may in

a clear Conclusion paragraph. That paragraph can be one sentence long, if necessary. And the best news of all is, you have already written that s

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

entence!

At the end of the Introduction (paragraph 1) of the Writing Task 1 report, you have written a summary of the information. In the same p

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

osition – at the end of the first paragraph – in Writing Task 2, you have written your Thesis Statement. Simply be repeating both of those senten

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

Combination pro

es at the beginning of a Conclusion paragraph, you have made your writing qualify as finished – even if there is more you wanted to write. And yo

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

u don’t lose a whole band point needlessly.

Here’s what you do:

1)Make sure you do write a good summary in Writing Task 1 and a good Thesis Sta

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

tement in Writing Task 2. (Your report and essay won’t work without them anyway.)

2)Watch your watch! No one is going to keep you on track as fa

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

r as elapsed time is concerned. It’s up to you to monitor your own progress.

3)In Writing Task 1, if 18 minutes have passed and you’re still wri

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

ting Body Paragraph sentences, finish the sentence you’re writing, quickly. Then, start a new paragraph (and make sure it looks like a new paragr

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

ph), and begin it with the words, “In conclusion,…” Then rewrite the summary. If you can, change a word or two (but not the meaning). If not, jus

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

Following aspects would a

t write it exactly the way you did at the end of the Introduction.

4)In Writing Task 2, if 38 minutes have passed and you’re still writing Body

dd to the challenges in developing combination products:

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

Paragraph sentences, finish the sentence you’re writing, quickly. Then, start a new paragraph (and make sure it looks like a new paragraph), and

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

begin it with the words, “In conclusion,…” Then rewrite the Thesis Statement. (This needs to be done in any case. It is an essential part of the

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

essay.)

5)Ideally, in Writing Task 2, you should write the Restatement in reverse order of the Thesis Statement. For example, if it is an opinio

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

essay, and you wrote your opinion and three reasons in the Thesis Statement, write the three reasons first, and then the opinion, in the Restate

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

Professional from academic institutions, pharmaceutical industries, health care indust

ment. Again, if you have time and can, change a word or two (but not the meaning). If not, just write it exactly the way you did at the end of t

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

he Introduction.

6)Make sure you finish these “In conclusion,…” sentences on time. The task ends at exactly 60 minutes.

Obviously, this will no

.

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

t save you any lost points if all you have is a few sentences and your essay is far too short in the first place. But if you have written most of

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

Companies that provide selfless information through particip

the essay, and followed the format, it’s essential that you not lost a whole band point just because it isn’t finished. So make it look finished

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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