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Firstly it is useful to understand the differences between digital and analog audio. This applies to any recordings, not just to recordings of voice for transcription. Analog machines, such as tape cassette recorders, record sounds as wave forms, the way that the

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

sound occurs in nature. Digital machines record sound by taking samples of the signal and storing them as bits of data, in the same way as a computer stores information. Because of the way the sounds are recorded digital recordings have a higher signal-to-noise ra

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

Examples of combination products may in

tio. Noise here refers to any background noise but when comparing analog to digital recordings it really refers to recorder-induced noise such as ‘tape hiss’. So the quality of the digital recording is better. That alone is a good reason to consider using digital

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

recording rather than analogue tapes!

There are other good reasons though. Not least of these is the fact that copies of analog recordings deteriorate in quality, so sending a copy of your master tape to a transcriptionist can result in a poor quality transcripti

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

n, because the quality of the audio is poor. Digital recordings can be copied again and again with no deterioration in quality because all that’s being copied is a series of bits of data.

Of course when using digital recordings you do need to check that your tran

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

Combination pro

scriptionist can transcribe from the file type you are using, or convert it. Most transcriptionists will be able to transcribe from any standard analog cassette and many can transcribe from micro and mini cassettes and video. So long as they have the relevant tape

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

transcription machine they can transcribe the tape. Not so, unfortunately, with digital.

Most digital audio file types are compressed and a codec (the algorithm used to reduce the number of bites contained in large files by eliminating redundant data) and the tr

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

nscriptionist or transcription software will need access to the codec that has produced the compressed file. However, this is often not an issue as PCs and many types of transcription software come with a variety of codecs already installed. It is certainly import

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

ant to check with your transcriptionist though that they can work with your file type. Please see my separate article on digital file types for transcription for more information on this.

Digital file types are also easily manipulated and this can be useful when

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

recording for transcription. If there are parts of the file you do not want transcribed it is a fairly simple matter to remove those parts and only send the transcriptionist the parts that should be transcribed. Alternatively, because a digital recording indicates

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

where you are in it second by second, you can send the transcriptionist instructions such as ‘transcribe between 3 minutes 20 seconds and 60 minutes 10 seconds.’ This does not work on analog media as, even if you and your transcriptionist both have tape players wi

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

Following aspects would a

th minute counters, the level of accuracy is quite poor.

Another huge benefit from the point of view of the transcription itself is that in a transcription from a digital recording your transcriptionist can mark the precise time that an inaudible word occurs. If

dd to the challenges in developing combination products:

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

that time is 3 minutes and 22 seconds then you can go back to your copy of the recording and almost instantly find 3 minutes and 22 seconds, play the word, and hopefully fill in the blank. With an analog recording on tape the transcriptionist can mark an inaudible

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

word but it's not possible to note the time with any degree of accuracy and you will either need to flick back and forth through the tape to find it or listen through the whole recording.

There are various ways to make a digital recording. Perhaps the commonest

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

hen recording for transcription is onto a card, in much the same way as a digital camera records pictures onto a card. The recorded files can then be transferred onto your computer and sent to your transcriptionist via email (if compressed), FTP, file sharing site

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

s or, in some cases, a file-sending box located on the transcriptionist’s website.

Minidiscs have an excellent sound quality but many transcriptionists are unable to transcribe from them as the data needs to be transferred to PC first and then usually converted f

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

Professional from academic institutions, pharmaceutical industries, health care indust

or use in transcription programmes.

DVDs and CDs also need to be converted before use in transcription software.

Recording can also be done directly onto a computer hard-drive using various types of software and an external microphone. However, when conducting i

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

terviews the presence of a laptop and large microphone might be rather intrusive.

However the recording is made and stored, it should be possible, with the right equipment and software, to convert the file into something you can download onto your PC and send to

.

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

your transcriptionist by one of the methods mentioned above. So digital recordings not only improve on quality but can save you time and money. Recordings can be ‘instantly’ transferred to the transcriptionist instead of posting audio cassettes, you save money on

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

Companies that provide selfless information through particip

postage costs to and from your transcriptionist and a better quality transcription will cost less to transcribe as it will take less time.

All in all, in a comparison between digital and analogue recording for transcription, digital recordings come out well ahead

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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