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There’s an awful lot of information about the Handfasting ceremony. Libraries carry books on the subject, specialty shops are selling special ribbons and cor

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

ds for the ceremony itself, and they’re even producing boxes and porringers which are perfect for holding the ribbons. Yet there are some practicalities that

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

Examples of combination products may in

make the Handfasting ceremony something of a challenge. How do you handle all those cords or ribbons before, during and after the ceremony?

If you’ve though

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

about the Handfasting ceremony but decided you know too little about it to go ahead, here’s the practical information you need to make it all happen smoothl

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

y and naturally.

1. Cords are easier to handle, so go for those rather than ribbons. However, if you’re only going to have one, it could be anything from a

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

Combination pro

ibbon to an exotic piece of material.

2. If you don’t want them carried in a container by your attendants, place them on the table with the rest of the para

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

hernalia either hanging across the table, or in a box or bowl.

3. Decide whether you want to use just one cord, or half a dozen.

4. If you use ribbons, you

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

can have them tied, or wrapped around your wrist. If you have cords, you could have a slip knot which can slide up like a noose.

5. Decide who will do the

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

ying – the celebrant or your attendants. If you’re using a number of cords, you could have each one tied by a different attendant – male and female alternate

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

y.

6. When the tying is in the process have either the celebrant speak, explaining what each cord stands for, or leave a card for each of the attendants wit

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

the cord. Each attendant will pick up the cord and read the words from the card.

7. Have a rehearsal. The whole handfasting ceremony. Begin where the celeb

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

Following aspects would a

rant calls the name of the attendant, the attendant walks to pick up the cord, returns with the cord, ties the couple’s hands, and walks back to his or her p

dd to the challenges in developing combination products:

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

ace. All the actions should be done slowly and ceremoniously. You might even consider having background music while it’s happening.

8. Inevitably, the cords

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

need to be taken off before the signing of the register. But here’s a thought. Although normally hands are tied crossed – bride’s right hand in groom’s right

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

hand – you might like to consider this. Have only your inside hands tied – that is if the groom is on the bride’s right arm, her right hand, and his left ha

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

ds are tied. If that happens, instead of removing the cords before the signing, you could continue to be tied during the signing. Probably make great photogr

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

Professional from academic institutions, pharmaceutical industries, health care indust

phs.

9. After the signing you return to where the ceremony began and are introduced as husband and wife. Before that happens, you could make the same ceremo

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

ny out of the untying, as you did with the tying. Again, everything should be done slowly, and perhaps the celebrant could be saying something then, as s/he

.

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

id when the tying was taking place.

10. As each cord is untied, it is returned to the place from which the attendant took it in the first place. When the wh

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

Companies that provide selfless information through particip

le wedding party is back in place, the celebrant greets the couple, and invites everyone to come up and give their best wishes to them.

And that says it all

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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