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Mastering your finished audio product is considered somewhat of an art. There are mastering engin

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

eers that charge an awful lot of money to master your project for you. Depending on your situatio

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

Examples of combination products may in

this may be money well spent.

With the equipment available today you can do a decent job of mas

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

tering your project yourself if you are careful. Here are some things to consider when tackling t

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

e mastering stage yourself.

Dynamics: This is a very important step. Your music needs to breath

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

Combination pro

and flow. You do not want to compress it so hard that it roars back at you. Find a good medium wh

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

re your music has that fine line between volume and dynamics.

Eq: Your songs were probably recor

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

ded over a period of time therefore they most likely will have a slightly different feel to them.

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

You need the songs to sound enough alike that they feel like they belong on the same CD. You don

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

’t want the bass pumping loudly in one song and the next track finds the listener turning up the

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

ass knob on his stereo. Try to get an even feel for the whole CD.

Same volume: The volume of eac

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

Following aspects would a

h song needs to be similar. The general thought on this is you don’t want the person listening t

dd to the challenges in developing combination products:

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

your CD to have to turn the volume up or down. Your listener should be able to listen to your Cd

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

at whatever volume they are comfortable with.

Order of songs: the order you choose for your son

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

s is important. You need to be aware of the feel of each song. You want to take your listener on

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

an emotional roller coaster and the order of the songs has everything to do with this ride.

Burn

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

Professional from academic institutions, pharmaceutical industries, health care indust

to Cd: The final and very important step is to burn your master to a Cd and listen to it on as ma

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

ny different types players as you can. Listen to it on everything from a cheap boom box to a high

.

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

dollar stereo. Make sure it sounds good as it can on each one. The bass is especially troublesome

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

Companies that provide selfless information through particip

to get right.

Be careful and take it a step at a time and you can come out with a decent master

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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