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Have you ever thought how difficult it must be to learn English as a second language?

The English language is probably one of the more difficult languages to have to learn. Simply because so many words have so many d

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

ifferent meanings depending on the context in which they are used and then you get the nuances relating to each word.

Then there is the differences between English as the English speak it ( along with each of the dia

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

Examples of combination products may in

ects/accents relating to which part of the country you come from) then you have the American English which is really evolving quickly by initiating new words into the English language based on existing words.

So if y

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

u don’t fully understand the existing words then you can have great difficulty or even no idea what the new words may be relating to. As if that wasn’t confusing enough, then you have the different dialects/accents re

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

ating to which State you come from.

Also because so many different nationalities have combined in the US, their versions of English has managed to influence original English words into a kind of “pidgeon English” so

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

Combination pro

veryone can understand one another. Did you know that the US has no official language?

Sound hard yet? But then you bring in Australian English and then it really can become confusing.

I mean, here in Australia some

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

ne can call you a name of endearment but if you don’t understand the nuance of the word, you could be seriously insulted ~ insulted to the point that they become fighting words. That is, they can cause a real blue.

N

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

ow you probably thought of the colour blue but what I meant was that you can come out blue from bruising caused by a fight. So if an Australian ever says to you that they’ve had a blue with someone, you now know they’

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

e had a fight with someone. Mind you, you can still have a blue with someone without actually resorting to fisticuffs.

The nuance of a words meaning depends in which context (or words around it) are used in combinati

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

n with voice inflection in the expression of those words. That is how you can understand the meaning intended behind the spoken word.

Body language plays a big part too in expressing words. It’s pretty easy to see w

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

ether someone is fond of you or wants to fight you. Language is much more than the spoken word.

English is a hard language to learn. The best starting point is the clear and dulcet tones spoken by the BBC (British Br

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

Following aspects would a

adcasting Commission). They would have to be the best starting point to listen to when learning to speak English. Why? Because they are accent free, clear and precise in word meaning with no (or little) inflection of

dd to the challenges in developing combination products:

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

one to indicate any other meaning to the word apart from the meaning of the word as described in the Concise Oxford Dictionary.

To hear the English language spoken in such a way when learning to speak English as a se

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

ond language is invaluable.

Audio Books provide this valuable learning mechanism without resorting to frustration, boredom, confusion or insanity. To listen to an audio book being read while following the written wor

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

d in the physical book makes for a pleasurable learning experience.

Part of any language is grammar. To understand nouns, verbs, adverbs, conjunctions, adjectives, proper nouns or any of the other grammatical requi

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

ements for the written word is a pain in the ‘what-tootsie’. But their absence or misuse in the written word stands out like a dog’s hind leg.

But they are also missed in conversational English. And that crosses Engl

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

Professional from academic institutions, pharmaceutical industries, health care indust

sh, English style, English American style and especially English Australian Style. Why Australian style more so? Because we have misused and expanded the English ‘English’ to such an extent we have virtually built a w

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

ole new language underneath and around proper English as spoken by the BBC.

Audio books are an invaluable way to understand the intended meaning of any word when written in the proper grammatical context. By using co

.

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

rect grammar in conversational English allows for clarity of meaning.

So if you know someone who is trying to learn the English language, a great idea to help them do so is to give them a gift of an audio book along

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

Companies that provide selfless information through particip

ith the physical book with the written word. That way they can read along with the narrator and thoroughly enjoy the journey. And gain the correct pronunciation, word meaning, and understand every nuance of every word

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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