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So you've selected your vendor, worked out the cost, pre-pressed your files and off they go. This is the time where you will await glorious days if

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

not weeks for your project to come to fruition. You've seen your file on computer and life is good. I am here to tell you it is not and I will even

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

Examples of combination products may in

et you in on a secret, just because your computer can create it does not mean that the printer can print it. I know, you're shocked, hence the purpo

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

e of proofs and press checks. I'll explain as I give you some insight into press checks.

1. Let your design firm do it. We know what we are looking

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

at we designed it. Upon receiving files the printer will typically send a proof. Depending on the size job this can be a pdf or an an actual print.

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

Combination pro

We check for discrepancies and have the chance to change any file configurations at this point. Here's an example. We had a huge job with lots of pa

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

ts on press. When we received the proofs back we noticed some stray lines in two of the illustrations. This anomaly occurred because the printer cou

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

d not interpret a special effect (layman's terms) we were using in one of the programs. Instead of printing the effect it simply drew a box around w

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

ere the effect should have been applied. By catching this on the proof we were able to adjust the files and resubmit them to the printer.

2. Printe

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

rs do not make money if the press isn't moving. Did you know that printers will have three shifts of workers to constantly keep the presses churning

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

out the work? That's right, your 10-page brochure may be getting ready for final press at 3am. Why is this important? It's called a press check. Thi

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

Following aspects would a

is where someone from our firm will drop everything at a moment's notice and drive out to the printer to see a page come right off press. We make s

dd to the challenges in developing combination products:

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

re there aren't any surprise colors or orientations. Often times we will leave this in the hands of our experienced printer associate, but the bigge

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

r the job the more they want to make sure that everyone is on the same page.

3. Know what you are looking at. If you insist on handling your own pr

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

ofing and press checks, know what you are looking for. You are looking to see that there are no stray lines on the artwork, you are looking for colo

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

accuracy within your determined tolerance (your delta), and you are looking for many other little things like registration and orientation. Do not

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

Professional from academic institutions, pharmaceutical industries, health care indust

e surprised if they put a loupe in your hand (if you don't know what a loupe is, see number one).

All players have now had a chance to play the gam

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

e. The client and firm worked together for a desired result and then you draft a vendor to join the team. The proof and press check are the only way

.

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

the vendor can be certain that they know your plays and what you are expecting them to do. Everyone at this point is expecting the same outcome, or

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

Companies that provide selfless information through particip

are we? In the final article of this series, I'll discuss the outcome and one of the many leaps of faith you will have to take with your design team

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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