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Wonderful scrapbooks can be created with only four supplies; an album, adhesive, paper and a corner rounder.

I remember being invited t

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

o a scrapbook party. Inwardly I groaned. I still draw stick figures. I have never possessed artistic ability. I remember almost crying

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

Examples of combination products may in

in school when we had to do an art project. I could envision great things, but I could not create them.

I’m a good sport and so I went

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

to the scrapbook party. The gal giving the demonstration had a demo album. Inside were lots of pictures all beautifully arranged. Everyo

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

ne was oohing and ahhing. Me, I was remembering those stick figures I was so good at drawing.

And then something magical happened. A li

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

Combination pro

ght bulb went off and I realized that artistic was not necessary. Creativity was not even needed. All that was needed were some basic su

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

pplies and I too could create an awesome scrapbook.

Many photos were “framed”. This simply means cutting a square piece of paper a litt

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

le larger than the photo and attaching the photo to the paper. I could do this. Cutting and pasting was something that did not need an a

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

rtist. This was actually fun. There are so many papers to choose from. You can mount photos on cardstock or directly on scrapbook paper

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

.

When I discovered a corner rounder, I was worried there would not be enough photos for me to round. A corner rounder literally slice

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

s off a sliver of paper making the corner round instead of square. You can use a corner rounder on both the photo and also on the paper

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

Following aspects would a

you are mounting the photo on.

If you did nothing else but put photos on paper and mounted them, some with the corners rounded, you’d

dd to the challenges in developing combination products:

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

have a scrapbook that looked really nice. If you have a 12x12 album and you put 5 photos on one page, you can arrange them any way you

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

want. You can overlap some of the frames. You can line them up. You can put one photo in each corner and then a rounded corner photo in

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

the middle. Again, we are using nothing but the photo and a frame. You can mix and match colors of the frames to make a really interesti

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

ng looking page.

I have always used double sided adhesive squares to mount photos to the frames. I find these very easy to use. You put

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

Professional from academic institutions, pharmaceutical industries, health care indust

one square on each of the four corners of the photo, pull off the tab to expose the tape and then press the photo on the frame. You the

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

n put four more squares on your frame and attach the frame to the paper. If the photo is extra large, I’ll put eight squares on the phot

.

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

o instead of four, and another eight on the frame.

My very first album used only these four supplies, an album, adhesive squares, paper

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

Companies that provide selfless information through particip

and a corner rounder. It’s an album I still cherish very much. You too can create a great scrapbook album with the same four supplies.

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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