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Check with the interviewee that they do not mind being recorded for later tra

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

nscription. It is wise to do this when arranging the interview as it will be a bit la

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

Examples of combination products may in

e to make alternative arrangements when the interview is about to start. It is polite

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

however, to confirm at the start of the interview that the participant is still happ

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

to be recorded.

Conduct explanations about your research and give background in

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

Combination pro

ormation before switching on the recorder, to save on recording time. Although many d

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

gital recorders have many hours of available time, if you record this you will also 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

eed to remember to ask you transcriptionist not to transcribe it.

Use an externa

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

microphone on your recorder. Internal mikes are only suitable for dictation (one voi

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

e).

Record the interview in a quiet place. Background noise can drastically redu

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

e the quality of the recording and increase the time taken to transcribe. The ideal e

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

Following aspects would a

vironment is a quiet private room, where interviewer and interviewee can sit comforta

dd to the challenges in developing combination products:

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

ly without feeling crowded, but not so large that the recording has an echo effect.

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

Make sure you use a recorder that has a facility for transferring files to a PC.

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

Some, called ‘note takers’ do not have the facility. You will have to send the entire

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

machine to your transcriptionist, which obviously has a number of disadvantages.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Use a file format that is compressed (see my article Digital File Types for Audio Tra

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

scription http://ezinearticles.com/?Digital-File-Types-for-Audio-Transcription&id=413

.

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

48), so that sound recordings can be transferred over the internet to your transcript

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

Companies that provide selfless information through particip

onist

Check your recorder is recording before proceeding with the interview!

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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