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Have you ever thought about how you’re going to work with your translated Word document once you get it back from your t

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

ranslation company? There are various issues to consider relating to fonts, whether you’re working in a Macintosh or PC e

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

Examples of combination products may in

vironment and how you’re going to identify the text once it’s translated into Simplified Chinese or Russian!

The first i

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

sue is fonts which can prove to be a tricky problem. If you’re working in a PC environment and using Windows XP 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

nable the fonts for various languages in Microsoft Office by going to:

Start > Programs > Microsoft Office Tools > Micro

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

Combination pro

oft Office Language Settings.

and add language settings to your system. This should at least allow you to view the docum

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

nt properly in Word and you can then think about the next stage, typesetting it for example, in Quark or InDesign. This

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

of course can present you with another set of problems. Unless you can identify clearly which bits of translated text cor

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

espond to the original English text you are going to have difficulties, particularly if it involves a complex layout. It’

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

not something to tackle unless you can perhaps have the layout of the final PDF checked by the original translator again

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

to check that everything is where it should be! It is indeed a brave non native speaking typesetter who tries to layout

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

Following aspects would a

ome Arabic or Urdu text which is also going to flow from right to left across the page!

If you are working in a Macintos

dd to the challenges in developing combination products:

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

environment you have a different set of problems to deal with as the fonts for the various languages for the Macintosh d

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

not come as standard and you will have problems viewing the translation in Word without them installed. In addition to t

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

his you’ll have the same problems mentioned above of identifying which bits of translated text go where. The best way aro

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

nd this is to ask your translation company to supply the translated text in EPS (Encapsulated PostScript) format which ca

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

Professional from academic institutions, pharmaceutical industries, health care indust

then be used in your Quark or InDesign file just like a graphic. This gets around the font issues. However, it would be

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

dvisable to have your translation company check the final layout in PDF format for missing text or inappropriate line bre

.

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

ks.

The advantage of having this all handled centrally by your translation company is that they are able to provide both

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

Companies that provide selfless information through particip

services and deliver the translated documents to you in PDF format and in your DTP source file layout ready for printing

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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