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It’s summer and that means vacations. Needlepoint can be a wonderful and relaxing activity during long hours waiting in airports and ri

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

ding in a car. Here are some tips, adapted from my book, NEEDLEPOINT TRADE SECRETS to help make stitching on vacation more enjoyable.

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

Examples of combination products may in

b>Needlepoint in the Car

Car trips are great times for doing needlepoint! The needlepoint you pick should either be worked "in han

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

d" (not on stretcher bars) or small.

Make sure you pack in your project bag scissors, a zipper bag to clean up your orts, threads, ins

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

ructions, and many extra needles. I can't tell you how many projects got delayed because I lost my only needle.

A car trip is a great

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

Combination pro

place to stitch large areas which use familiar stitches. I often reserve projects like this for trips.

Needlepoint in Hotel Rooms
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
>

Hotel rooms usually use lower wattage bulbs and this can make it hard to see. You can pack a 100 watt bulb in your luggage and chang
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
e it when you get to the room.

Many hotels now have special fixtures which use fluorescent bulbs and you can't do this. If this happen
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
to you, sit near the window during the day to stitch. Using lighter colors or larger mesh also helps.

But to be sure you have enough
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
light, no matter what, get a small project lamp which is battery operated. If you're going on a long trip, be sure to pack extra batter
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
es -- they can be hard to find n foreign countries.

Needlepoint in your Luggage

Don't leave your needlepoint on stretcher bars
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a
in your luggage. Take it off the bars and store it with the threads. Group the bars with a rubber band and pack them. Your tacks will h
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
ave to go into you checked luggage.

I always pack an extra project in my suitcase to work on if I finish my current project.

Before y
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
u leave be sure you have ALL the threads you need and all instructions. You may not be near a place to buy more.

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

It's OK to take needlepoint on board planes, although the regulations about scissors and cutters change often. In 2007, sci
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
sors are OK, but round cutters are not. The safest bet is to have a pair of bunt-tipped child's scissors you use just for traveling.

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

Professional from academic institutions, pharmaceutical industries, health care indust
ut your name and address in any project bag you have. If you lose it, this might bring it back to you.

I always pack an extra small pr
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ject (my airplane project) in my tote bag. Having this to do keeps me happy and busy even when the flight from SF is delayed 3 hours be
.

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
cause of fog.

The light in airplanes, especially at night, is poor, the battery-operated project light is perfect for planes.

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

Companies that provide selfless information through particip
wer planes don't have ashtrays, getting rid of orts is a problem. Use you empty glass or bring on a small zipper bag you can throw away

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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