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Thanks to Apple, complete amateurs can make impressive video productions and share them with friends on DVDs. All that is needed is a digital video camera, a Macinto

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

sh computer with a Superdrive (one which will burn DVDs), and the iLife suite of applications which normally come with Macs, and of course, a bit of good taste and d

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

Examples of combination products may in

iscretion. This I know from actual experience, and I’ll try to share how it can be done.

In February of 2003, monks from Atma Jyoti Ashram, a small Hindu monastery

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

in Southern California, went on a pilgrimage to India, visiting holy places throughout the country. Being lovers of India, we wished to record outstanding events fro

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

m out journey so we could share them with friends and relive them ourselves through our videos and photos. We took over twenty hours of video in our two month sojour

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

Combination pro

, and when we returned, we faced the task of editing the footage to make viewing more manageable.

We had a 1 Ghz iMac and iMovie–Apple’s entry level movie editing a

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

pplication–so we proceeded to hook our Mini-DV camera up to the Mac with a fire-wire cable and import footage using iMovie’s import feature. There was a lot of foota

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

ge that was either poorly filmed, too long, or uninteresting in retrospect. That still left lots of film to work with. We began by getting an overview of what was av

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

ailable, and putting together a mental picture of the story we wanted to tell with the video. Then, by placing bits of video in the “timeline” of clips, the story we

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

wanted to tell began to take shape.

To learn the best way to make a video that did not have the hallmarks of amateurism, a search on Google yielded gobs of tutoria

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

s, tips, and techniques for using iMovie, and video editing in general.

When the clips were arranged to our satisfaction in the timeline, we proceeded to add audio

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

Following aspects would a

and music (using iTunes–iMovie is well integrated with this and other iLife applications) to supplement the audio on the clips so as to make for more continuity. The

dd to the challenges in developing combination products:

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

n we added transitions (which iMovie provides in abundance) between clips to give the video a more polished look. Then came the titles, subtitles, and effects, which

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

began to turn what started as a mess of random footage into a cohesive, semi-professional looking (O.K., at least not totally amateurish) bit of video. Then came th

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

e agonizing step of taking an objective look at the end results and pruning out footage to make it more succinct, then tweaking features to give it the final finish

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

d look.

After creating a few short features of this sort, we then used iDvd to create an accomplished looking DVD. iDvd makes it easy by supplying quite an array of

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

Professional from academic institutions, pharmaceutical industries, health care indust

professional looking Themes, or allowing you to modify and edit existing Themes, or create your own. We then imported the final video featurettes into the desired T

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

heme, and proceeded to burn our DVD. Earlier versions of iDvd were a bit buggy in the burning process, but have improved in later releases.

Those wishing more optio

.

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

ns for video editing and DVD burning can use Apple’s mid and pro level applications, Final Cut Express and Final Cut Pro and DVD Studio Pro.

The end result surprise

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

Companies that provide selfless information through particip

d us and those we showed it to. So our pleasant experience has solidified us as Mac addicts, though we needed no convincing as to the usefulness of Apple’s products

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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