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Your fingers can be powerful tools to help your young child develop speech and

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

language. Following are three ideas that I have found to be helpful in my spe

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

Examples of combination products may in

ch-language therapy practice. I hope you find them helpful too.

Finger Cue

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

ing
Finger cueing will help your child to watch the movement of your

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

ips and tongue to see how sounds are made. Gently tap your lip with your index

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

Combination pro

finger as you say words for your child. For short words tap once for every sou

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

nd. For longer words tap once for every syllable.

Finger Pacing
F

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

nger pacing will help your child: 1. Put more words together and 2. Understand

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

more of what you say. As you are talking hold up one finger at a time for eac

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

word that you say. This helps your child to see how to put words together and

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

to see that your sentences are made up of separate words. The more you do this

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

Following aspects would a

the easier it gets.

To do finger pacing and cueing at the same time use repe

dd to the challenges in developing combination products:

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

ition. Say either the single word with finger cueing first and then say the wo

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

rd in a phrase with finger pacing or the other way around. Either way the more

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

you repeat the more your child will learn.

Expansion
Expansion he

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

ps your child put more words together. When your child says a single word say

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

Professional from academic institutions, pharmaceutical industries, health care indust

two words back. For example if your child says, “ball” say back “red ball”, “m

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

ball”, “ball gone” whatever fits. When your child says two words say back thr

.

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

ee, and so on. To make this more powerful use Finger Pacing as you say back th

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

Companies that provide selfless information through particip

words.

I hope these ideas help. You’ll be amazed at what your fingers can do

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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